PS 3000 DIGATAL PHOTOSPOT SYSTEM— 510(k) K030061

Substantially Equivalent

Precise Optics

FDA 510(k) clearance K030061 for PS 3000 DIGATAL PHOTOSPOT SYSTEM, Substantially Equivalent on 2003-04-07. Applicant: Precise Optics.

Clearance details

Applicant: Precise Optics
Product code: Code OWB
Advisory panel: Radiology
Date received: 2003-01-07
Decision date: 2003-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.