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510(k) K913055

THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 by Atomic Products Corp. — Product Code IZD

K913055 is an FDA 510(k) premarket notification submitted by Atomic Products Corp. for the device "THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900". The FDA issued a decision of Substantially Equivalent on September 6, 1991. The device falls under product code IZD (Probe, Uptake, Nuclear), a Class I device regulated under 21 CFR 892.1320. Atomic Products Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1991
Date Received
July 9, 1991
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 Atomic Products Corp.

  • K915541 — SPECT TABLE, MODEL #056-760 (January 17, 1992)
  • K904187 — ECONOMY C-ARM TABLE, MODEL # 056-005 (November 29, 1990)
  • K904623 — RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235 (November 6, 1990)
  • K900851 — DIGITAL IMAGE ENHANCEMENT SYSTEM (May 11, 1990)
  • K895799 — RECTILINEAR SCANNER MODEL #187-270 (February 1, 1990)
  • K884312 — ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 (February 16, 1989)
  • K871868 — VENTI-SCAN II (April 11, 1988)
  • K874332 — MRI STRETCHER (January 5, 1988)
  • K790835 — DYNAJECT (June 22, 1979)

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