SHIMADZU CATHETERIZATION C-ARM STAND MH-50A— 510(k) K875157

Name: FDA 510(k) clearance K875157
Creator: U.S. Food and Drug Administration
Published: 1988-01-19

Substantially Equivalent

Shimadzu Precision Instruments, Inc.

FDA 510(k) clearance K875157 for SHIMADZU CATHETERIZATION C-ARM STAND MH-50A, Substantially Equivalent on 1988-01-19. Applicant: Shimadzu Precision Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Shimadzu Precision Instruments, Inc.
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1987-12-15
Decision date: 1988-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, 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 Shimadzu Precision Instruments, Inc.

view all

K940294 — SHIMADZU MOBILE X-RAY SYSTEMS1994-03-16
K890913 — SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT1989-09-06
K884598 — SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-12001989-04-20
K884477 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B1989-03-15
K875378 — SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION1988-11-16

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.