The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Dicom Viewer.
| Device ID | K153653 |
| 510k Number | K153653 |
| Device Name: | DICOM Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | Brainlab AG Kapellenstr. 12 Feldkirchen, DE 85622 |
| Contact | Rainer Birkenbach |
| Correspondent | Alexander Schwiersch Brainlab AG Kapellenstr. 12 Feldkirchen, DE 85622 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481139070 | K153653 | 000 |
| 04056481007102 | K153653 | 000 |