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510(k) K943504

RSX-525HF by Fischer Imaging Corp. — Product Code IZO

K943504 is an FDA 510(k) premarket notification submitted by Fischer Imaging Corp. for the device "RSX-525HF". The FDA issued a decision of Substantially Equivalent on August 17, 1994. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Fischer Imaging Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1994
Date Received
July 20, 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

Other clearances by Fischer Imaging Corp.

  • K042095 — MAMMOTEST (October 29, 2004)
  • K021113 — MAMMOPATH (June 13, 2002)
  • K981414 — LC POSITIONER (July 16, 1998)
  • K973400 — MAMMOTEST ADAPTER DRIVER (November 10, 1997)
  • K964806 — MD-1835 (March 4, 1997)
  • K961207 — EP-X BIPLANE (August 20, 1996)
  • K961022 — TANGENT VI TABLE (May 3, 1996)
  • K945619 — ATHENA HFX (March 23, 1995)
  • K950291 — DIGITAL 625HF (March 23, 1995)
  • K944149 — MICRO X-80 HF (September 16, 1994)

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)
  • K950040 — SII 525 APR (March 21, 1995)
  • K950041 — SII 360 APR (March 21, 1995)

FDA data resources