The following data is part of a premarket notification filed by Velocity Medical Solutions, Llc with the FDA for Velocityais, Velocity Ai, Velocityvx, Velocityrt, V-response.
| Device ID | K081076 |
| 510k Number | K081076 |
| Device Name: | VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE |
| Classification | System, Image Processing, Radiological |
| Applicant | VELOCITY MEDICAL SOLUTIONS, LLC 1733 CANTON LANE Marietta, GA 30062 |
| Contact | Paul Sumner |
| Correspondent | Paul Sumner VELOCITY MEDICAL SOLUTIONS, LLC 1733 CANTON LANE Marietta, GA 30062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-16 |
| Decision Date | 2008-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854393006008 | K081076 | 000 |