The following data is part of a premarket notification filed by Velocity Medical Solutions, Llc with the FDA for Velocityais.
Device ID | K070248 |
510k Number | K070248 |
Device Name: | VELOCITYAIS |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-25 |
Decision Date | 2007-03-01 |
Summary: | summary |