Home / 510(k) Clearances / K910020

510(k) K910020

CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS by Capintec Instruments, Inc. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1991
Date Received
January 3, 1991
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 Capintec Instruments, Inc.

  • K943072 — BETA C COUNTER (September 29, 1994)
  • K935539 — CAPINTEC CRC 35R (February 18, 1994)
  • K930962 — CAPTUS 2000 WEL COUNTER (May 18, 1993)
  • K924586 — CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE (December 3, 1992)
  • K921428 — CAPTUS 500 (May 28, 1992)
  • K905796 — DOSE CALIBRATOR (March 18, 1991)

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)