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510(k) K190330

DRX-Evolution/Plus with Dual Energy by Carestream Health, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2019
Date Received
February 14, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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Other clearances for product code KPR

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  • K242119 — INNOVISION-EXII (January 3, 2025)
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