ACU007S— 510(k) K092522

Substantially Equivalent

Oncology Systems, Inc.

FDA 510(k) clearance K092522 for ACU007S, Substantially Equivalent on 2009-11-20. Applicant: Oncology Systems, Inc.. Device class: 2.

Clearance details

Applicant
Oncology Systems, Inc.
Product code
Code KXK
Device class
Class 2
Regulation
21 CFR 892.5730
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Champaign, IL, US
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