PROTON BEAM THERAPY SYSTEM (PBTS)— 510(k) K992414

Name: FDA 510(k) clearance K992414
Creator: U.S. Food and Drug Administration
Published: 2000-07-21

Substantially Equivalent

Optivus Technology, Inc.

FDA 510(k) clearance K992414 for PROTON BEAM THERAPY SYSTEM (PBTS), Substantially Equivalent on 2000-07-21. Applicant: Optivus Technology, Inc.. Device class: 2.

Clearance details

Applicant: Optivus Technology, Inc.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1999-07-20
Decision date: 2000-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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