SCEPTREP3 PET/CT— 510(k) K042428

Substantially Equivalent

Hitachi Medical Systems America, Inc.

FDA 510(k) clearance K042428 for SCEPTREP3 PET/CT, Substantially Equivalent on 2004-09-17. Applicant: Hitachi Medical Systems America, Inc..

Clearance details

Applicant: Hitachi Medical Systems America, Inc.
Product code: Code KPS
Advisory panel: Radiology
Date received: 2004-09-08
Decision date: 2004-09-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Twinsburg, OH, US

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