D2RS_AT Digital Dynamic Remote System— 510(k) K150306

Name: FDA 510(k) clearance K150306
Creator: U.S. Food and Drug Administration
Published: 2015-10-10

Substantially Equivalent

Stephanix Radiological Solutions

FDA 510(k) clearance K150306 for D2RS_AT Digital Dynamic Remote System, Substantially Equivalent on 2015-10-10. Applicant: Stephanix Radiological Solutions. Device class: 2.

Clearance details

Applicant: Stephanix Radiological Solutions
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2015-02-09
Decision date: 2015-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Ricamarie, FR

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.