FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK— 510(k) K921112

Substantially Equivalent

Fujifilm Medical System U.S.A., Inc.

FDA 510(k) clearance K921112 for FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK, Substantially Equivalent on 1993-04-27. Applicant: Fujifilm Medical System U.S.A., Inc..

Clearance details

Applicant: Fujifilm Medical System U.S.A., Inc.
Product code: Code KPR
Advisory panel: Radiology
Date received: 1992-03-09
Decision date: 1993-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.