VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE— 510(k) K081076
Substantially EquivalentVelocity Medical Solutions, LLC
FDA 510(k) clearance K081076 for VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE, Substantially Equivalent on 2008-06-20. Applicant: Velocity Medical Solutions, LLC. Device class: 2.
Clearance details
- Applicant
- Velocity Medical Solutions, LLC
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marietta, GA, US
Recent devices under product code LLZ
view allMore clearances from Velocity Medical Solutions, LLC
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K081076
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081076.
Data sourced from openFDA. This site is unofficial and independent of the FDA.