Cleared Traditional

DigiX FDX

K162529 · Allengers Medical Systems Limited · Radiology
Mar 2017
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K162529 is an FDA 510(k) clearance for the DigiX FDX, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Allengers Medical Systems Limited (Derabassi, Distt Mohali, IN). The FDA issued a Cleared decision on March 3, 2017, 175 days after receiving the submission on September 9, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K162529 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2016
Decision Date March 03, 2017
Days to Decision 175 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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