The following data is part of a premarket notification filed by Oehm Und Rehbein Gmbh with the FDA for Dicompacs, Model 5.2, Dicompacs Dx-r, Model 1.4.
| Device ID | K091364 |
| 510k Number | K091364 |
| Device Name: | DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 |
| Classification | System, Image Processing, Radiological |
| Applicant | OEHM UND REHBEIN GMBH 55 NORTHERN BLVD. SUITE 200 Great Neck, NY 11021 |
| Contact | Alan Schwartz |
| Correspondent | Alan Schwartz OEHM UND REHBEIN GMBH 55 NORTHERN BLVD. SUITE 200 Great Neck, NY 11021 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-08 |
| Decision Date | 2009-12-11 |
| Summary: | summary |