The following data is part of a premarket notification filed by Medis Medical Imaging Systems, B.v. with the FDA for Quantitative Vascular Angiography - Cms.
| Device ID | K023970 |
| 510k Number | K023970 |
| Device Name: | QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS |
| Classification | System, X-ray, Angiographic |
| Applicant | MEDIS MEDICAL IMAGING SYSTEMS, B.V. POORTGEBOUW RIJNSBURGERWEG 10 Leiden, NL 2333 Aa |
| Contact | J I Hollander |
| Correspondent | J I Hollander MEDIS MEDICAL IMAGING SYSTEMS, B.V. POORTGEBOUW RIJNSBURGERWEG 10 Leiden, NL 2333 Aa |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-29 |
| Decision Date | 2003-01-24 |
| Summary: | summary |