510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810873Substantially Equivalent

Star

Intl. General Electric Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810873 is the FDA 510(k) clearance record for STAR, a class II device, cleared for Intl. General Electric Co. on under FDA product code JWM (System, Tomographic, Nuclear). FDA records list one 510(k) clearance for Intl. General Electric Co. As of , FDA records show no recalls naming K810873.

Clearance record

Decision date
Received
(23 days to decision)
Product code
JWM System, Tomographic, Nuclear
Regulation
21 CFR 892.1310
Device class
Class II
Review panel
Radiology
Applicant
Intl. General Electric Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JWM

Trailing 12 months

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

FDA records show no clearances under product code JWM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JWM, 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