ZIEHM VISION 2— 510(k) K073346
Substantially EquivalentZiehm Imaging, Inc.
FDA 510(k) clearance K073346 for ZIEHM VISION 2, Substantially Equivalent on 2008-03-21. Applicant: Ziehm Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Ziehm Imaging, Inc.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Riverside, CA, US
Recent devices under product code JAK
view allMore clearances from Ziehm Imaging, Inc.
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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 K073346
K-number listed on FDA's recall record- Z-0575-2025 — Ziehm Vision system, x-ray, tomography, computed.
- Z-2644-2016 — Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
- Z-0564-2014 — Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
- Z-0565-2014 — Ziehm Vision(2) 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 K073346.
Data sourced from openFDA. This site is unofficial and independent of the FDA.