MED-SEG, MODEL BTMS 1000— 510(k) K092328

Substantially Equivalent

Bartron Medical Imaging, Inc.

FDA 510(k) clearance K092328 for MED-SEG, MODEL BTMS 1000, Substantially Equivalent on 2010-07-26. Applicant: Bartron Medical Imaging, Inc..

Clearance details

Applicant: Bartron Medical Imaging, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2009-08-04
Decision date: 2010-07-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Dedham, MA, 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.