The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Interventional Workspot.
| Device ID | K121296 |
| 510k Number | K121296 |
| Device Name: | INTERVENTIONAL WORKSPOT |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
| Contact | Frans Jacobs |
| Correspondent | Frans Jacobs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-30 |
| Decision Date | 2013-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838059191 | K121296 | 000 |