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510(k) K940294

SHIMADZU MOBILE X-RAY SYSTEMS by Shimadzu Precision Instruments, Inc. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1994
Date Received
January 21, 1994
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 Shimadzu Precision Instruments, Inc.

  • K890913 — SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT (September 6, 1989)
  • K884598 — SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 (April 20, 1989)
  • K884477 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B (March 15, 1989)
  • K875378 — SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION (November 16, 1988)
  • K882311 — SHIMADZU LATERAL C-ARM MH-31 (September 14, 1988)
  • K881674 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC (September 2, 1988)
  • K874910 — SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200 (July 1, 1988)
  • K881795 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K (July 1, 1988)
  • K875370 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX (May 18, 1988)
  • K874946 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 (March 3, 1988)

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