DIGISCOPE RX-2 (9 OPTION)— 510(k) K965013

Name: FDA 510(k) clearance K965013
Creator: U.S. Food and Drug Administration
Published: 1997-01-17

Substantially Equivalent

Medirex, Inc.

FDA 510(k) clearance K965013 for DIGISCOPE RX-2 (9 OPTION), Substantially Equivalent on 1997-01-17. Applicant: Medirex, Inc.. Device class: 2.

Clearance details

Applicant: Medirex, Inc.
Product code: Code OXO
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1996-12-16
Decision date: 1997-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley Hills, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.