id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2001-N-0178-0053,FDA,FDA-2001-N-0178,"Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32,
1020.33); Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff",Other,Guidance,2023-02-22T05:00:00Z,2023,2,2023-02-22T05:00:00Z,,2024-11-07T00:47:49Z,,1,0,09000064856e13af
FDA-2001-N-0178-0052,FDA,FDA-2001-N-0178,"Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide",Other,Guidance,2023-02-22T05:00:00Z,2023,2,2023-02-22T05:00:00Z,,2023-02-22T14:25:08Z,,0,0,09000064845683d4
FDA-2001-N-0178-0041,FDA,FDA-2001-N-0178,Attachment 1 Gofman 2002 What Are the Main Critiques of the 1999 Study re: Comment from John W. Gofman,Supporting & Related Material,Background Material,2016-02-03T05:00:00Z,2016,2,,,2016-02-03T15:03:20Z,,0,0,0900006481e4a4f9
FDA-2001-N-0178-0043,FDA,FDA-2001-N-0178,"Attachment 3 Gofman 1999, Executive Summary re: Comment from John W. Gofman",Supporting & Related Material,Background Material,2016-02-03T05:00:00Z,2016,2,,,2016-02-03T15:07:54Z,,0,0,0900006481e4a4fb
FDA-2001-N-0178-0042,FDA,FDA-2001-N-0178,Attachment 2 Critique by Arthur C. Upton re: Comment from John W. Gofman,Supporting & Related Material,Background Material,2016-02-03T05:00:00Z,2016,2,,,2016-02-03T15:05:26Z,,0,0,0900006481e4a4fa
FDA-2001-N-0178-0011,FDA,FDA-2001-N-0178,Reference 2 FDA Guidance Document Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices re:  Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T14:55:55Z,,0,0,0900006481e42afa
FDA-2001-N-0178-0024,FDA,FDA-2001-N-0178,"Reference 25 Gkanatsios, et al evaluation of an On-Line Patient Exposure Meter in Neuroradiology re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components",Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:13:34Z,,0,0,09000064804e15af
FDA-2001-N-0178-0033,FDA,FDA-2001-N-0178,Tab B Changes of Initial Draft (FRN) Submitted to OIRA for Review and Action re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:23:32Z,,0,0,09000064804e15df
FDA-2001-N-0178-0015,FDA,FDA-2001-N-0178,Reference 17 Council Directive 97/43 euration Health Protection of Individuals Against the Dangers of Ionizing Radiation in Relation to Medical Exposure re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T16:23:45Z,,0,0,0900006481e427ab
FDA-2001-N-0178-0012,FDA,FDA-2001-N-0178,Reference 9 FDA CDRH Handbook of Selected Tissue Doses for Fluoroscopic and Cineangiographic Examination of the Coronary Arteries re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T15:21:49Z,,0,0,0900006481e42af4
FDA-2001-N-0178-0027,FDA,FDA-2001-N-0178,"Reference 29 Stern et al Estimated Benefits of Proposed Amendments to the FDA Radiation-Safety Standard for Diagnostic X-ray Equipment 2001 FDA Science Forum,
Wash, DC, February 15 thru 16, 2001 re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components",Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:16:26Z,,0,0,09000064804e15aa
FDA-2001-N-0178-0025,FDA,FDA-2001-N-0178,"Reference 26 Geise, R. et al Radiation Doses during Pediatric Radiofrequency Catheter Ablation Procedures, PACE re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components",Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:14:04Z,,0,0,09000064804e15ad
FDA-2001-N-0178-0028,FDA,FDA-2001-N-0178,"Reference 30 Committee on Interagency Radiation Research and Policy Coordination Science Use of BEIR V AND UNSCEAR 1988 in Radiation Risk Assessment, December 1992 re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components",Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:16:56Z,,0,0,09000064804e15c6
FDA-2001-N-0178-0029,FDA,FDA-2001-N-0178,Reference 31 Sources and Effects of Ionizing Radiation United Nations Scientific Committee on the Effects of Atomic Radiation re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:17:52Z,,0,0,09000064804e15c9
FDA-2001-N-0178-0031,FDA,FDA-2001-N-0178,Memorandum from OMB OIRA to FDA DDM,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:22:39Z,,0,0,09000064804e15e9
FDA-2001-N-0178-0018,FDA,FDA-2001-N-0178,Reference 20 FDA Recording Information in the Patient's Medical Record that Identifies the Potential for Serious X-ray Induced Skin Injuries Following Fluoroscopically Guided Procedures re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:01:06Z,,0,0,0900006481e427a8
FDA-2001-N-0178-0020,FDA,FDA-2001-N-0178,"Reference 8 Proceedings of the ACR/FDA Workshop on Fluroscopy Strategies for Improvement in Performance, Radiation Safety and Control October 16 & 17, 1992 re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Part 2 of 3",Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:06:42Z,,0,0,09000064804e15d4
FDA-2001-N-0178-0026,FDA,FDA-2001-N-0178,Reference 27 Transcript of Proceedings Twenty-fifth Meeting of the Technical Electronic Product Radiation Safety Standards Committee September 1998 re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:14:40Z,,0,0,09000064804e15c4
FDA-2001-N-0178-0017,FDA,FDA-2001-N-0178,Reference 19 FDA Public Health Advisory: Avoidance of Serious x-ray Induced Skin Injuries to Patients during Fluoroscopically-Guided Procedures re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T16:53:47Z,,0,0,0900006481e427a9
FDA-2001-N-0178-0021,FDA,FDA-2001-N-0178,"Reference 8 Proceedings of the ACR/FDA Workshop on Fluroscopy Strategies for Improvement in Performance, Radiation Safety and Control October 16 & 17, 1992 re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Part 3 of 3",Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:06:56Z,,0,0,09000064804e15dc
FDA-2001-N-0178-0034,FDA,FDA-2001-N-0178,Memorandum from OMB OIRA to FDA DDM,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:25:19Z,,0,0,09000064804e1639
FDA-2001-N-0178-0019,FDA,FDA-2001-N-0178,"Reference 8 Proceedings of the ACR/FDA Workshop on Fluroscopy Strategies for Improvement in Performance, Radiation Safety and Control October 16 & 17, 1992 re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Part 1 of 3",Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:06:26Z,,0,0,09000064804e15d0
FDA-2001-N-0178-0016,FDA,FDA-2001-N-0178,Reference 18 FDA Avoidance of Serious X-ray Induced Skin Injuries to Patients during Fluoroscopically-Guided Procedures re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T16:35:41Z,,0,0,0900006481e427aa
FDA-2001-N-0178-0013,FDA,FDA-2001-N-0178,"Reference 10 Rudin and Bednarek Spatial Shaping of the Beam: Collimation, Grids, Equalization Filters, and Region-of-Interest Fluoroscopy re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components",Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T15:27:20Z,,0,0,0900006481e42af3
FDA-2001-N-0178-0014,FDA,FDA-2001-N-0178,Reference 11 Solomon et al Low-exposure Scanning-beam X-ray Fluoroscopy System re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T15:31:58Z,,0,0,0900006481e42af2
FDA-2001-N-0178-0023,FDA,FDA-2001-N-0178,"Reference 23 Bauml, et al Joint WHO/ISH Workshop on Efficacy and Radiation safety in Interventional Radiology re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components",Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:12:27Z,,0,0,09000064804e15b2
FDA-2001-N-0178-0036,FDA,FDA-2001-N-0178,Tab B Changes of Initial Draft (FRN 70FR33998) Submitted to OMB OIRA for Review and Action re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:26:14Z,,0,0,09000064804e1634
FDA-2001-N-0178-0030,FDA,FDA-2001-N-0178,"Reference 33 FDA CDRH November 15, 2000 Assessment of the Impact of the Proposed Amendments to the Diagnostic X-ray Equipment Performance Standard Addressing Fluoroscopic X-ray Systems re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components",Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:19:54Z,,0,0,09000064804e15cd
FDA-2001-N-0178-0022,FDA,FDA-2001-N-0178,"Reference 21 Rosenstein, M. et al., DHHS FDA Handbook of Selected Tissue Doses for the Upper Gastrointestinal Fluoroscopic Examination re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components",Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:10:35Z,,0,0,09000064804e15be
FDA-2001-N-0178-0035,FDA,FDA-2001-N-0178,Tab A Initial Draft (FRN 70FR33998) Submitted to OMB OIRA for Review re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:25:47Z,,0,0,09000064804e163b
FDA-2001-N-0178-0032,FDA,FDA-2001-N-0178,Tab A Initial Draft (FRN) Submitted to OMB OIRA for Review re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-02T05:00:00Z,2016,2,,,2016-02-02T17:23:06Z,,0,0,09000064804e15e4
FDA-2001-N-0178-0010,FDA,FDA-2001-N-0178,List of References re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Supporting & Related Material,Background Material,2016-02-01T05:00:00Z,2016,2,,,2016-02-01T17:13:23Z,,0,0,09000064804e15d8
FDA-2001-N-0178-0009,FDA,FDA-2001-N-0178,Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components; Correction,Proposed Rule,Correction,2015-03-17T04:00:00Z,2015,3,,,2016-02-01T17:10:32Z,,0,0,09000064804e1595
FDA-2001-N-0178-0008,FDA,FDA-2001-N-0178,"Letter from FDA CDRH to GE OEC Medical Systems, Inc.",Other,Letter(s),2006-05-08T04:00:00Z,2006,5,,,2016-02-02T17:47:04Z,,0,0,09000064804e164b
FDA-2001-N-0178-0007,FDA,FDA-2001-N-0178,Letter from FDA CDRH to GE Heathcare,Other,Letter(s),2006-05-08T04:00:00Z,2006,5,,,2016-02-02T17:43:54Z,,0,0,09000064804e1648
FDA-2001-N-0178-0006,FDA,FDA-2001-N-0178,Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Notice,Notice of Approval,2005-06-30T04:00:00Z,2005,6,2005-06-29T04:00:00Z,2007-01-01T04:59:59Z,2016-02-02T17:35:36Z,,0,0,09000064804e1632
FDA-2001-N-0178-0005,FDA,FDA-2001-N-0178,Cover Sheet for Supporting Statement,Supporting & Related Material,Background Material,2005-06-30T04:00:00Z,2005,6,,,2016-02-03T16:20:48Z,,0,0,09000064804e162f
FDA-2001-N-0178-0004,FDA,FDA-2001-N-0178,Supporting Statement for Performance Standard for Diagnostic X-RAY Systems and Their Major Components,Supporting & Related Material,Background Material,2005-06-30T04:00:00Z,2005,6,,,2016-02-03T16:16:57Z,,0,0,09000064804e162d
FDA-2001-N-0178-0003,FDA,FDA-2001-N-0178,Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Pages 101 through 170,Rule,Notice of Final Rule,2005-06-21T04:00:00Z,2005,6,2005-06-09T04:00:00Z,,2016-02-02T17:30:52Z,70FR33998,0,0,09000064804e1628
FDA-2001-N-0178-0002,FDA,FDA-2001-N-0178,Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Pages 1 through 100,Rule,Notice of Final Rule,2005-06-21T04:00:00Z,2005,6,2005-06-09T04:00:00Z,,2016-02-02T17:29:43Z,,0,0,09000064804e1623
FDA-2001-N-0178-0001,FDA,FDA-2001-N-0178,Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2002-12-10T05:00:00Z,2002,12,2002-12-10T05:00:00Z,2003-04-10T03:59:59Z,2016-02-03T22:01:16Z,,0,0,09000064804e1548