HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM— 510(k) K140899

Substantially Equivalent

Halo Medical Technologies, LLC

FDA 510(k) clearance K140899 for HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM, Substantially Equivalent on 2014-05-05. Applicant: Halo Medical Technologies, LLC.

Clearance details

Applicant: Halo Medical Technologies, LLC
Product code: Code IYO
Advisory panel: Radiology
Date received: 2014-04-08
Decision date: 2014-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.