X-POSURE SYSTEM VERSION 2 RAD— 510(k) K002500
Substantially EquivalentPronosco A/S
FDA 510(k) clearance K002500 for X-POSURE SYSTEM VERSION 2 RAD, Substantially Equivalent on 2000-10-23. Applicant: Pronosco A/S. Device class: 2.
Clearance details
- Applicant
- Pronosco A/S
- Product code
- Code KGI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1170
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code KGI
view allMore clearances from Pronosco A/S
view allAdverse events under product code KGI
product code KGI- 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.