The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Abvs Workplace.
| Device ID | K092067 |
| 510k Number | K092067 |
| Device Name: | ABVS WORKPLACE |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS AG, MEDICAL SOLUTIONS HENESTRASSE 127 Erlangen, DE D-91052 |
| Contact | Shelly Pearce |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-07-09 |
| Decision Date | 2009-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869006840 | K092067 | 000 |
| 04056869006833 | K092067 | 000 |
| 04056869001067 | K092067 | 000 |