PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER— 510(k) K935580

Substantially Equivalent

Precise Optics

FDA 510(k) clearance K935580 for PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER, Substantially Equivalent on 1994-03-16. Applicant: Precise Optics.

Clearance details

Applicant: Precise Optics
Product code: Code OXO
Advisory panel: Radiology
Date received: 1993-11-18
Decision date: 1994-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bay Shore, NY, US

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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.