ZIEHM VISION— 510(k) K011292

Name: FDA 510(k) clearance K011292
Creator: U.S. Food and Drug Administration
Published: 2001-06-20

Substantially Equivalent

Ziehm International, Inc.

FDA 510(k) clearance K011292 for ZIEHM VISION, Substantially Equivalent on 2001-06-20. Applicant: Ziehm International, Inc.. Device class: 2.

Clearance details

Applicant: Ziehm International, Inc.
Product code: Code OWB
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2001-04-30
Decision date: 2001-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverside, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWB

view all

K253726 — uAngio AVIVA CX2026-08-21
K261413 — EXTRON 3; EXTRON 62026-08-19
K254205 — Zenition 302026-08-07
K260607 — Shield System (Siemens 30x40)2026-07-31
K253670 — SmartCT (R3.0 (L10))2026-07-10

More clearances from Ziehm International, Inc.

view all

K910455 — IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR1991-02-14
K902196 — MODIFIED STICK-GARD SAFETY NEEDLE1990-06-26
K894021 — MOBILE X-RAY UNIT1989-09-01
K894041 — PUMP-JECT SYRINGE WITH LUER-LOCK1989-08-28
K890620 — STICK-GARD SAFETY NEEDLE1989-02-28

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.