3D-DOCTOR— 510(k) K003746

Substantially Equivalent

Able Software Corp.

FDA 510(k) clearance K003746 for 3D-DOCTOR, Substantially Equivalent on 2001-03-13. Applicant: Able Software Corp..

Clearance details

Applicant: Able Software Corp.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2000-12-04
Decision date: 2001-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, 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.