Recognition List Number: 027 Publication Date: 08/02/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-230: NEMA XR 24-2008, Primary user controls for interventional angiography x-ray equipment. (Radiology)
Date of Standard: 2008. |
| Address of Standards Organization: |
| National Electrical Manufacturers Association (NEMA) |
| 1300 North 17th Street |
| Suite 1847 |
| Rosslyn, VA 22209 |
| |
|
| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) |
|
| (2) | OFFICE OF COMMUNICATION EDUCATION AND RADIATION PROGRAM (OCER) |
|
| (3) | OFFICE OF COMPLIANCE (OC) |
|
|
| Devices Affected: |
| Interventional fluroscopy equipment |
|
| Processes Affected: |
|
| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
|
| 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 |
| §892.1650 |
System, X-Ray, Fluoroscopic, Image-Intensified |
Class 2 |
JAA |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1700 |
Generator, High-Voltage, X-Ray, Diagnostic |
Class 1 |
IZO |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1720 |
System, X-Ray, Mobile |
Class 2 |
IZL |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Donald Miller, M.D., F.A.C.R. |
| FDA/CDRH/OCER |
| 10903 New Hampshire Avenue Builiding 66, Room 4553 |
| Silver Spring MD 20993 |
| 301/796-3299 |
| Email: donald.miller@fda.hhs.gov |
|
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