Home / 510(k) Clearances / K883081

510(k) K883081

RADKOR, XG-515 by Radkor, Inc. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1988
Date Received
July 21, 1988
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 Radkor, Inc.

  • K895969 — RADKOR DXG-650R (November 13, 1989)
  • K892196 — RADKOR TS10-B (April 26, 1989)
  • K891395 — RADKOR BS-10 AND BS-10T (April 3, 1989)
  • K883885 — RADKOR, RF-159 (October 19, 1988)
  • K883864 — RADKOR SFR-70 (October 19, 1988)
  • K881701 — RADKOR SFC-21 (September 8, 1988)
  • K881700 — RADKOR KOB-84 (September 2, 1988)
  • K881696 — RADKOR XG-325 (September 2, 1988)
  • K882563 — RADKOR, CST-18 (July 8, 1988)

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)