DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4— 510(k) K091364
Substantially EquivalentOehm Und Rehbein GmbH
FDA 510(k) clearance K091364 for DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4, Substantially Equivalent on 2009-12-11. Applicant: Oehm Und Rehbein GmbH.
Clearance details
- Applicant
- Oehm Und Rehbein GmbH
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
Adverse 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.