V2465P X-RAY IMAGE INTENSIFIER— 510(k) K896331

Name: FDA 510(k) clearance K896331
Creator: U.S. Food and Drug Administration
Published: 1989-12-22

Substantially Equivalent

Hamamatsu Photonics K.K.

FDA 510(k) clearance K896331 for V2465P X-RAY IMAGE INTENSIFIER, Substantially Equivalent on 1989-12-22. Applicant: Hamamatsu Photonics K.K.. Device class: 2.

Clearance details

Applicant: Hamamatsu Photonics K.K.
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1989-11-02
Decision date: 1989-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgewater, NJ, 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.