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510(k) K926056

9600 FLUOROSCOPIC IMAGING SYSTEM by Oec-Diasonics, Inc. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1993
Date Received
December 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image-Intensified Fluoroscopic X-Ray System, Mobile
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Fluoroscopy of the human body.

Other clearances by Oec-Diasonics, Inc.

  • K924879 — EP 3000 (January 4, 1993)
  • K914446 — UROVIEW 2000, MODIFICATION (January 10, 1992)
  • K896583 — F.A.S.T. TABLE (March 1, 1990)
  • K893475 — UROVIEW II (August 10, 1989)
  • K872022 — UROVIEW (July 16, 1987)
  • K864837 — MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM (January 30, 1987)
  • K843972 — ANGIOPLUS-S (January 3, 1985)

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  • K240828 — OEC One ASD (December 27, 2024)
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  • K192819 — OEC Elite (November 8, 2019)