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510(k) K942731

SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR by Shimadzu Corp. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1994
Date Received
May 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High-Voltage, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1700
Review Panel
RA
Submission Type

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  • K953831 — N 800 HF (September 8, 1995)
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  • K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X- (July 6, 1995)
  • K950883 — POLYDOROS SX 65 AND 80 (April 3, 1995)
  • K950694 — COMPACT-X (March 31, 1995)
  • K950291 — DIGITAL 625HF (March 23, 1995)
  • K950041 — SII 360 APR (March 21, 1995)
  • K945453 — UD 150L-R II (March 21, 1995)