The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Quentry Dose Review.
| Device ID | K141199 |
| 510k Number | K141199 |
| Device Name: | QUENTRY DOSE REVIEW |
| Classification | System, Image Processing, Radiological |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Alexander Schwiersch |
| Correspondent | Alexander Schwiersch BRAINLAB AG KAPELLENSTRASSE 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 | 2014-05-09 |
| Decision Date | 2014-06-20 |
| Summary: | summary |