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510(k) K151221

Kubtec DIGIVIEW 395 by Kub Technologies, Inc. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2015
Date Received
May 7, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K141539 — KUBTEC X250 (October 29, 2014)
  • K103348 — DIGIVIEW 250 (October 20, 2011)
  • K083510 — KUBTEC XPERT 20 (January 8, 2009)
  • K071233 — XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM (June 20, 2007)

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