Cleared Traditional

SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB

K101289 · Air Techniques, Inc. · Radiology
Aug 2010
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K101289 is an FDA 510(k) clearance for the SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Air Techniques, Inc. (Melville, US). The FDA issued a Cleared decision on August 3, 2010, 88 days after receiving the submission on May 7, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K101289 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2010
Decision Date August 03, 2010
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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