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510(k) K173018

MDR17 Mobile Direct Radiographic System by Del Medical, Inc. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2017
Date Received
September 28, 2017
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by Del Medical, Inc.

  • K223550 — DMX (April 10, 2023)
  • K152767 — OTC12D AUTO RADIOGRAPHIC SYSTEM (December 14, 2015)
  • K140825 — DELWORKS DR SYSTEM (July 17, 2014)

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