WITT BIOMEDICAL IMAGE III— 510(k) K945582

Name: FDA 510(k) clearance K945582
Creator: U.S. Food and Drug Administration
Published: 1995-06-19

Substantially Equivalent

Witt Biomedical Corporation

FDA 510(k) clearance K945582 for WITT BIOMEDICAL IMAGE III, Substantially Equivalent on 1995-06-19. Applicant: Witt Biomedical Corporation. Device class: 2.

Clearance details

Applicant: Witt Biomedical Corporation
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1994-11-14
Decision date: 1995-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Witt Biomedical Corporation

view all

K010058 — IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK2001-03-21
K973474 — WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS1998-03-13
K950436 — WITT BIOMEDICAL SERIES IV1995-11-02
K923054 — WITT BIOMEDICAL SERIES II-EP1993-02-25
K880258 — WITT BIOMEDICAL VX-801988-06-16

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.