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FDA 510(k), K002519, VITREA 2, VERSION 2.1
FDA 510(k), K002519, VITREA 2, VERSION 2.1
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510(K) Number: K002519
Device Name: VITREA 2, VERSION 2.1
Manufacturer: ROBERT C SAMEC
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 08/15/2000
Decision Date: 10/19/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: VITREA 2, VERSION 2.1
Manufacturer: ROBERT C SAMEC
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 08/15/2000
Decision Date: 10/19/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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