OPHTHASCAN 'S' MINI-A— 510(k) K893035

Substantially Equivalent

Biophysic Medical, Inc.

FDA 510(k) clearance K893035 for OPHTHASCAN 'S' MINI-A, Substantially Equivalent on 1989-06-12. Applicant: Biophysic Medical, Inc..

Clearance details

Applicant: Biophysic Medical, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1989-04-24
Decision date: 1989-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Hill, CA, 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.