POD B-SCAN— 510(k) K070884

Substantially Equivalent

Starfish Product Engineering, Inc.

FDA 510(k) clearance K070884 for POD B-SCAN, Substantially Equivalent on 2007-04-11. Applicant: Starfish Product Engineering, Inc..

Clearance details

Applicant: Starfish Product Engineering, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2007-03-30
Decision date: 2007-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victoria, B.C.,, CA

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.