FATHOM CMP-1000— 510(k) K930051

Substantially Equivalent

Fathom Ent., Inc.

FDA 510(k) clearance K930051 for FATHOM CMP-1000, Substantially Equivalent on 1993-07-20. Applicant: Fathom Ent., Inc..

Clearance details

Applicant: Fathom Ent., Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1993-01-06
Decision date: 1993-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beckley, WV, 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.