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510(k) K983768

MODIFICATION TO GAMMA GUIDANCE SYSTEM by Radiation Monitoring Devices, Inc. — Product Code IZD

K983768 is an FDA 510(k) premarket notification submitted by Radiation Monitoring Devices, Inc. for the device "MODIFICATION TO GAMMA GUIDANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 2, 1999. The device falls under product code IZD (Probe, Uptake, Nuclear), a Class I device regulated under 21 CFR 892.1320. Radiation Monitoring Devices, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1999
Date Received
October 26, 1998
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 Radiation Monitoring Devices, Inc.

  • K961321 — GAMMA GUIDANCE SYSTEM (February 10, 1997)

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)
  • 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)
  • K932153 — THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME (September 7, 1993)

FDA data resources