CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM— 510(k) K933473

Name: FDA 510(k) clearance K933473
Creator: U.S. Food and Drug Administration
Published: 1993-11-24

Substantially Equivalent

Shimadzu Corp.

FDA 510(k) clearance K933473 for CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM, Substantially Equivalent on 1993-11-24. Applicant: Shimadzu Corp.. Device class: 2.

Clearance details

Applicant: Shimadzu Corp.
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1993-07-15
Decision date: 1993-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kyoto City 604 Japan, JP

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 Shimadzu Corp.

view all

K142341 — X-RAY TV SYSTEM SONIALVISION G42015-03-06
K131075 — X-RAY TV SYSTEM SONIAL VISION G42014-03-28
K101039 — SHIMADZU COLLIMATOR R-3002010-09-20
K101036 — SHIMADZU COLLIMATOR R-20J2010-08-26
K090578 — SHIMADZU COLLIMATOR R-30H2009-11-06

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.