The following data is part of a premarket notification filed by Medis Medical Imaging Systems, B.v. with the FDA for X-ray Vva.
| Device ID | K112807 |
| 510k Number | K112807 |
| Device Name: | X-RAY VVA |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDIS MEDICAL IMAGING SYSTEMS, B.V. 9 SCHUTTERSVELD Leiden, NL 2316 Xg |
| Contact | D.j.w. Bierhuizen |
| Correspondent | D.j.w. Bierhuizen MEDIS MEDICAL IMAGING SYSTEMS, B.V. 9 SCHUTTERSVELD Leiden, NL 2316 Xg |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-27 |
| Decision Date | 2012-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B141QANGIOXA730 | K112807 | 000 |
| B141MEDISSUITEXA2D20180 | K112807 | 000 |
| B141MEDISSUITEXA2D20190 | K112807 | 000 |