The following data is part of a premarket notification filed by Medsynaptic Private, Ltd. with the FDA for Medsynapse Pacs Software.
| Device ID | K093247 |
| 510k Number | K093247 |
| Device Name: | MEDSYNAPSE PACS SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDSYNAPTIC PRIVATE, LTD. 8726 FERRARA CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MEDSYNAPTIC PRIVATE, LTD. 8726 FERRARA CT Naples, FL 34114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-15 |
| Decision Date | 2009-12-02 |
| Summary: | summary |