MCA-601, C-ARM MOBILE— 510(k) K993896

Name: FDA 510(k) clearance K993896
Creator: U.S. Food and Drug Administration
Published: 2000-03-27

Substantially Equivalent

Medison Radiology Systems, Inc.

FDA 510(k) clearance K993896 for MCA-601, C-ARM MOBILE, Substantially Equivalent on 2000-03-27. Applicant: Medison Radiology Systems, Inc.. Device class: 2.

Clearance details

Applicant: Medison Radiology Systems, Inc.
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1999-11-16
Decision date: 2000-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glenview, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAA

view all

K253103 — Nexus DRF Digital X-ray Imaging System2026-05-29
K251650 — Insight Enhanced DRF (EN-1002-01)2025-09-16
K242488 — Soteria E-View2025-01-06
K242948 — Adora DRFi (04550010)2024-12-23
K233380 — TRIDENT Mobile Fluoroscopy System2024-06-26

More clearances from Medison Radiology Systems, Inc.

view all

K002685 — CORDLESS COMPACT MOBILE X-RAY SYSTEM2000-09-15

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.