TRANS X 100 CHEST FILM CHANGER— 510(k) K900562

Name: FDA 510(k) clearance K900562
Creator: U.S. Food and Drug Administration
Published: 1990-04-10

Substantially Equivalent

Acoma Medical Imaging, Inc.

FDA 510(k) clearance K900562 for TRANS X 100 CHEST FILM CHANGER, Substantially Equivalent on 1990-04-10. Applicant: Acoma Medical Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Acoma Medical Imaging, Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1990-02-07
Decision date: 1990-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheeling, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.