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510(k) K920115

MEDISCINT by Oakfield Instruments, Ltd. — Product Code IZD

K920115 is an FDA 510(k) premarket notification submitted by Oakfield Instruments, Ltd. for the device "MEDISCINT". The FDA issued a decision of Substantially Equivalent on March 30, 1992. The device falls under product code IZD (Probe, Uptake, Nuclear), a Class I device regulated under 21 CFR 892.1320. Oakfield Instruments, Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1992
Date Received
January 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Uptake, Nuclear
Device Class
Class I
Regulation Number
892.1320
Review Panel
RA
Submission Type

Other clearances by Oakfield Instruments, Ltd.

  • K964804 — FLEXILOG LS (August 6, 1997)
  • K964589 — FLEXILOG 3000 (March 4, 1997)
  • K961895 — FLEXILOG LS 13921 (November 4, 1996)
  • K945069 — FLEXILOG 2000 (June 13, 1995)
  • K902460 — CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) (August 28, 1990)
  • K896288 — FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM (May 4, 1990)
  • K894902 — SOURCERER (October 17, 1989)

Other clearances for product code IZD

  • K133781 — DECLIPSESPECT LAPAROSCOPY (April 11, 2014)
  • K123917 — DECLIPSESPECT VIEWER (January 25, 2013)
  • K101887 — CONFIDENT SURGERY SUITE 300, MODEL CSS300 (March 22, 2011)
  • K013751 — HANDHELD GAMMA FINDER (HGF) (February 6, 2002)
  • K983768 — MODIFICATION TO GAMMA GUIDANCE SYSTEM (July 2, 1999)
  • K982442 — C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) (August 25, 1998)
  • K971167 — NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (June 26, 1997)
  • K961321 — GAMMA GUIDANCE SYSTEM (February 10, 1997)
  • K962319 — NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES (September 13, 1996)
  • K942580 — NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (February 9, 1995)

FDA data resources