The following data is part of a premarket notification filed by Sterling Diagnostic Imaging, Inc. with the FDA for Ultra-vision Mammography Detail, Ultra-vision Mammography Fast Detail.
| Device ID | K974423 |
| 510k Number | K974423 |
| Device Name: | ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL |
| Classification | Screen, Intensifying, Radiographic |
| Applicant | STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 19048 MAIL DROP 102 Greenville, SC 29602 -9048 |
| Contact | Jean E Barlett |
| Correspondent | Jean E Barlett STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 19048 MAIL DROP 102 Greenville, SC 29602 -9048 |
| Product Code | EAM |
| CFR Regulation Number | 892.1960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-24 |
| Decision Date | 1997-12-22 |
| Summary: | summary |