DIGITAL ADD-ON BUCKY— 510(k) K970136

Substantially Equivalent

Swissray Teleray AG

FDA 510(k) clearance K970136 for DIGITAL ADD-ON BUCKY, Substantially Equivalent on 1997-11-21. Applicant: Swissray Teleray AG.

Clearance details

Applicant: Swissray Teleray AG
Product code: Code KPR
Advisory panel: Radiology
Date received: 1997-01-15
Decision date: 1997-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Liverpool, NY, 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.