The following data is part of a premarket notification filed by Jamieson Film Co. with the FDA for Kodak Cardiology Digital Archive & Review System.
| Device ID | K960043 |
| 510k Number | K960043 |
| Device Name: | KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | JAMIESON FILM CO. HEALTH SCIENCES DIVISION 901 ELMGROVE ROAD Rochester, NY 14653 -5741 |
| Contact | Barry Keys |
| Correspondent | Barry Keys JAMIESON FILM CO. HEALTH SCIENCES DIVISION 901 ELMGROVE ROAD Rochester, NY 14653 -5741 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-03 |
| Decision Date | 1996-03-27 |