A-SCAN PLUS CONNECT— 510(k) K123349

Substantially Equivalent

Accutome, Inc.

FDA 510(k) clearance K123349 for A-SCAN PLUS CONNECT, Substantially Equivalent on 2013-01-29. Applicant: Accutome, Inc..

Clearance details

Applicant: Accutome, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2012-10-31
Decision date: 2013-01-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Malvern, PA, 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.