UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE— 510(k) K936136
Substantially EquivalentGe Dec Medical Systems
FDA 510(k) clearance K936136 for UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE, Substantially Equivalent on 1994-01-25. Applicant: Ge Dec Medical Systems. Device class: 2.
Clearance details
- Applicant
- Ge Dec Medical Systems
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code JAA
view allMore clearances from Ge Dec Medical Systems
view allAdverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
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.