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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K241346
Device Name IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
Applicant
Aspen Imaging Healthcare, Inc.
801 Jupiter Rd. Suite 200
Plano,  TX  75074
Applicant Contact Casey Lee
Correspondent
Mtech Group, LLC
7505 Fannin St. Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/13/2024
Decision Date 11/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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