Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-238: NEMA PS 3.1 - 3.20 (2011), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
Date of Standard: 2011. |
| Address of Standards Organization: |
| National Electrical Manufacturers Association (NEMA) |
| 1300 North 17th Street |
| Suite 1847 |
| Rosslyn, VA 22209 |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) |
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| (2) | OFFICE OF COMMUNICATION EDUCATION AND RADIATION PROGRAM (OCER) |
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| (3) | OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL) |
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| Devices Affected: |
| Picture Archiving and Communications Systems (PACS), Telemedicine Systems |
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| Processes Affected: |
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| Type of Standard: |
| National, Horizontal |
| Extent of Recognition: |
| Complete standard and any annexes |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1650 |
Solid State X-Ray Imager (Flat Panel/Digital Imager) |
Class 2 |
MQB |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1750 |
System, X-Ray, Tomography, Computed |
Class 2 |
JAK |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.2050 |
System, Image Processing, Radiological |
Class 2 |
LLZ |
| |
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| Relevant Guidance: |
Guidance for Industry: Guidance for the Submission of Premarket Notifications for Medical Image Management Devices. Document issued on: July 27, 2000
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073720.htm
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System. Document issued on: November 5, 2010
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107552.htm
Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions. Document issued on: May 30, 2008
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107549.htm
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| FDA Technical Contact: |
| Kish Chakrabarti |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room G308 |
| Silver Spring MD 20993 |
| 301/796-6539 |
| Email: kish.chakrabarti@fda.hhs.gov |
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