ZIEHM VISION RFD— 510(k) K083545
Substantially EquivalentZiehm Imaging, Inc.
FDA 510(k) clearance K083545 for ZIEHM VISION RFD, Substantially Equivalent on 2009-05-15. Applicant: Ziehm Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Ziehm Imaging, Inc.
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Riverside, CA, US
Recent devices under product code OWB
view allMore clearances from Ziehm Imaging, Inc.
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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 K083545
K-number listed on FDA's recall record- Z-2641-2016 — Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
- Z-0568-2014 — Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083545.
Data sourced from openFDA. This site is unofficial and independent of the FDA.