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510(k) K954666

MPH50, MPH65, AND MPH80 by GE Medical Systems — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1995
Date Received
October 10, 1995
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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  • K241242 — SIGNA MAGNUS (October 17, 2024)
  • K233750 — ECG-less Cardiac (April 2, 2024)
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Other clearances for product code IZO

  • 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)
  • K950040 — SII 525 APR (March 21, 1995)
  • K945453 — UD 150L-R II (March 21, 1995)