COMPASS— 510(k) K072374
Substantially EquivalentScanditronix Wellhofer GmbH
FDA 510(k) clearance K072374 for COMPASS, Substantially Equivalent on 2007-12-07. Applicant: Scanditronix Wellhofer GmbH. Device class: 2.
Clearance details
- Applicant
- Scanditronix Wellhofer GmbH
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Schwarzenbruck, DE
Recent devices under product code IYE
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
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 →
Recalls naming K072374
K-number listed on FDA's recall record- Z-1212-2015 — COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
- Z-0168-2015 — COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
- Z-0456-2014 — iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072374.
Data sourced from openFDA. This site is unofficial and independent of the FDA.