The following data is part of a premarket notification filed by Medis Medical Imaging Systems, B.v. with the FDA for Quantitative Analysis Of Coronary Angiograms (qca).
| Device ID | K993763 |
| 510k Number | K993763 |
| Device Name: | QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) |
| Classification | System, X-ray, Angiographic |
| Applicant | MEDIS MEDICAL IMAGING SYSTEMS, B.V. 109 DANBURY RD. Ridgefield, CT 06877 |
| Contact | Douglas F Orr |
| Correspondent | Douglas F Orr MEDIS MEDICAL IMAGING SYSTEMS, B.V. 109 DANBURY RD. Ridgefield, CT 06877 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-08 |
| Decision Date | 1999-11-26 |
| Summary: | summary |