SafeCT-29— 510(k) K153331
Substantially EquivalentMedic Vision Imaging Solutions
FDA 510(k) clearance K153331 for SafeCT-29, Substantially Equivalent on 2016-05-17. Applicant: Medic Vision Imaging Solutions. Device class: 2.
Clearance details
- Applicant
- Medic Vision Imaging Solutions
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tirat Carmel, IL
Recent devices under product code JAK
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.