Name: Predicase
Price: 199 USD

K-number	K251645
Device name	Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP
Applicant	Canon Medical Systems Corporation
Product code	JAK
Device class	Class II
Decision date	Sep 26, 2025
Decision	Substantially Equivalent
Regulation	892.1750

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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

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