HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE— 510(k) K913264

Substantially Equivalent

Mallinckrodt Group, Inc.

FDA 510(k) clearance K913264 for HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE, Substantially Equivalent on 1991-11-01. Applicant: Mallinckrodt Group, Inc..

Clearance details

Applicant: Mallinckrodt Group, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1991-07-23
Decision date: 1991-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.