FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM— 510(k) K051025

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K051025 for FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM, Substantially Equivalent on 2005-05-13. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 2005-04-22
Decision date: 2005-05-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.