PLATINUM DRF IMAGING SYSTEM— 510(k) K131766

Name: FDA 510(k) clearance K131766
Creator: U.S. Food and Drug Administration
Published: 2013-12-12

Substantially Equivalent

Apelem-Dms Group

FDA 510(k) clearance K131766 for PLATINUM DRF IMAGING SYSTEM, Substantially Equivalent on 2013-12-12. Applicant: Apelem-Dms Group. Device class: 2.

Clearance details

Applicant: Apelem-Dms Group
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2013-06-17
Decision date: 2013-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashland, MA, US

Download summary PDF View on FDA.gov ↗

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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.