Class Class II

Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP (K251645)

K251645 2025-09-26 Traditional
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Description

Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP by Canon Medical Systems Corporation, an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251645
Clearance Date2025-09-26
Clearance TypeTraditional
Product CodeJAK
Regulation Number892.1750

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