510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780395Substantially Equivalent

Imager, Body Section, Radionuclide

Union Carbide Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780395 is the FDA 510(k) clearance record for IMAGER, BODY SECTION, RADIONUCLIDE, a class I device, cleared for Union Carbide Corp. on under FDA product code IYW (Scanner, Rectilinear, Nuclear). FDA records list 69 510(k) clearances for Union Carbide Corp., from to . As of , FDA records show no recalls naming K780395.

Clearance record

Decision date
Received
(18 days to decision)
Product code
IYW Scanner, Rectilinear, Nuclear
Regulation
21 CFR 892.1300
Device class
Class I
Review panel
Radiology
Applicant
Union Carbide Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IYW

Trailing 12 months

FDA records hold no clearances under product code IYW in the trailing twelve months.

FDA records show no clearances under product code IYW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IYW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260