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510(k) K152767

OTC12D AUTO RADIOGRAPHIC SYSTEM by Del Medical, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2015
Date Received
September 24, 2015
Clearance Type
Abbreviated
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

Other clearances by Del Medical, Inc.

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  • K140825 — DELWORKS DR SYSTEM (July 17, 2014)

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  • K242019 — GXR-Series Diagnostic X-Ray System (January 7, 2025)
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  • K242119 — INNOVISION-EXII (January 3, 2025)
  • K241068 — uDR 780i (November 1, 2024)