BONEVUE— 510(k) K083691

Substantially Equivalent

Micromri, Inc.

FDA 510(k) clearance K083691 for BONEVUE, Substantially Equivalent on 2009-02-25. Applicant: Micromri, Inc..

Clearance details

Applicant: Micromri, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2008-12-12
Decision date: 2009-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

Download summary PDF View on FDA.gov ↗

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.