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510(k) K945668

KXO-80G by Toshiba America Medical Systems, In.C — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1994
Date Received
November 17, 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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Other clearances for product code IZO

  • K954666 — MPH50, MPH65, AND MPH80 (November 24, 1995)
  • K953582 — HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR (September 26, 1995)
  • K953831 — N 800 HF (September 8, 1995)
  • K952822 — SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G (July 12, 1995)
  • 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)