RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE— 510(k) K982862
Substantially EquivalentApplicare Medical Imaging, B.V.
FDA 510(k) clearance K982862 for RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE, Substantially Equivalent on 1998-10-21. Applicant: Applicare Medical Imaging, B.V.. Device class: 2.
Clearance details
- Applicant
- Applicare Medical Imaging, B.V.
- 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
- Traditional
- Location
- Rockville, MD, US
Recent devices under product code LLZ
view allMore clearances from Applicare Medical Imaging, B.V.
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.