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510(k) K981880

DX-480, ADD ON DIGITAL IMAGER by Wuestec Medical, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1998
Date Received
May 28, 1998
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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  • K974240 — LIGHTLINE-M (December 22, 1997)
  • K960083 — MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 (July 24, 1996)
  • K955414 — XRT 400 (July 24, 1996)
  • K935123 — SUPERSTAND 300 (March 27, 1996)
  • K933253 — SUPERSTAND 3000 (August 16, 1993)

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