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510(k) K884598

SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 by Shimadzu Precision Instruments, Inc. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1989
Date Received
November 3, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Shimadzu Precision Instruments, Inc.

  • K940294 — SHIMADZU MOBILE X-RAY SYSTEMS (March 16, 1994)
  • K890913 — SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT (September 6, 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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