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510(k) K934686

MOLYBDENUM/RHODIUM FILTERS by Continental X-Ray Corp. — Product Code IZO

K934686 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "MOLYBDENUM/RHODIUM FILTERS". The FDA issued a decision of Substantially Equivalent on May 26, 1994. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1994
Date Received
September 29, 1993
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 Continental X-Ray Corp.

  • K972442 — CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 (September 11, 1997)
  • K962140 — ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITION (July 25, 1996)
  • K961690 — CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 (June 27, 1996)
  • K954581 — ARC SERIES (December 21, 1995)
  • K950571 — LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 (March 31, 1995)
  • K942175 — LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 (August 17, 1994)
  • K942100 — MODEL TM EP HIGH VOLTAGE GENERATOR (June 7, 1994)
  • K931724 — ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES (June 14, 1993)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 1993)
  • K921986 — PATIENT INFORMATION MANAGER (PIM) (October 16, 1992)

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

FDA data resources