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510(k) K101779

CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM by Jpi Healthcare Co, Ltd. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2011
Date Received
June 25, 2010
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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  • K955706 — JPI AUTOMATIC X-RAY FILM PROCESSOR (February 12, 1996)
  • K954161 — JPI INTENSIFYING SCREEN (February 2, 1996)
  • K950043 — JPI AUTOMATIC X-RAY FILM PROCESSOR (May 10, 1995)

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