MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)— 510(k) K981856

Substantially Equivalent

Greatbatch Scientific

FDA 510(k) clearance K981856 for MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR), Substantially Equivalent on 1998-07-29. Applicant: Greatbatch Scientific.

Clearance details

Applicant: Greatbatch Scientific
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 1998-05-27
Decision date: 1998-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

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Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.