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510(k) K780395

IMAGER, BODY SECTION, RADIONUCLIDE by Union Carbide Corp. — Product Code IYW

K780395 is an FDA 510(k) premarket notification submitted by Union Carbide Corp. for the device "IMAGER, BODY SECTION, RADIONUCLIDE". The FDA issued a decision of Substantially Equivalent on March 31, 1978. The device falls under product code IYW (Scanner, Rectilinear, Nuclear), a Class I device regulated under 21 CFR 892.1300. Union Carbide Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1978
Date Received
March 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scanner, Rectilinear, Nuclear
Device Class
Class I
Regulation Number
892.1300
Review Panel
RA
Submission Type

Other clearances by Union Carbide Corp.

  • K830337 — MARK III OXYGEN WALKER SYS-LOW PRESS (March 17, 1983)
  • K820836 — MARK III OXYGEN WALKER SYSTEM (April 15, 1982)
  • K820535 — LASER GAS MIXTURES (March 31, 1982)
  • K812536 — LINDE MARK II (September 23, 1981)
  • K810732 — LINDE MARK II OXYGEN RESERV. TYPE OR-4 (March 27, 1981)
  • K810596 — CENTRIFI CHEM SYSTEM 400 ANALYZER (March 17, 1981)
  • K810129 — CENTRIFICHEM SYSTEM 500 (February 2, 1981)
  • K803216 — CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT (January 9, 1981)
  • K802741 — CENTRIFICHEM COMB. SERUM-BASED CALIB. (December 10, 1980)
  • K802520 — CENTRIFICHEM PIPETTOR ACCURACY CALIB. (November 12, 1980)

Other clearances for product code IYW

  • K944684 — POLYSCAN DIGITAL SCANNER (May 15, 1995)
  • K895799 — RECTILINEAR SCANNER MODEL #187-270 (February 1, 1990)
  • K882453 — POLYSCAN DIGITAL SCANNER (November 23, 1988)

FDA data resources