The following data is part of a premarket notification filed by Medsynaptic Private Ltd with the FDA for Medsynapse Ris Pacs & Medsynapse Vna.
| Device ID | K192508 |
| 510k Number | K192508 |
| Device Name: | Medsynapse Ris Pacs & Medsynapse VNA |
| Classification | System, Image Processing, Radiological |
| Applicant | Medsynaptic Private Ltd 5th Floor, Mantri Galleria, Off S.B. Road Model Colony Shivaji Nagar, IN 411016 |
| Contact | Ashish Dhawad |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello 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 | 2019-09-12 |
| Decision Date | 2019-11-22 |