R2 DIGITALNOW HD(DIGITALNOW HD)— 510(k) K091368

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K091368 for R2 DIGITALNOW HD(DIGITALNOW HD), Substantially Equivalent on 2009-06-04. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2009-05-08
Decision date: 2009-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, 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.