ADC COMPACT (AGFA DIAGNOSTIC CENTER)— 510(k) K974597

Substantially Equivalent

Bayer Corp., Agfa Div.

FDA 510(k) clearance K974597 for ADC COMPACT (AGFA DIAGNOSTIC CENTER), Substantially Equivalent on 1998-03-09. Applicant: Bayer Corp., Agfa Div..

Clearance details

Applicant: Bayer Corp., Agfa Div.
Product code: Code KPR
Advisory panel: Radiology
Date received: 1997-12-09
Decision date: 1998-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridgefield Park, NJ, 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.