The following data is part of a premarket notification filed by Sterling Diagnostic Imaging, Inc. with the FDA for Sterling Diagnostic Imaging Direct Radiography.
| Device ID | K973206 |
| 510k Number | K973206 |
| Device Name: | STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 6101 BUILDING 600/MAILBOX 630 Newark, DE 19714 -6101 |
| Contact | Elaine H Kindell |
| Correspondent | Elaine H Kindell STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 6101 BUILDING 600/MAILBOX 630 Newark, DE 19714 -6101 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-26 |
| Decision Date | 1997-12-04 |
| Summary: | summary |