510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K052839Substantially Equivalent

CT Perfusion 4

GE Healthcare, Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052839 is the FDA 510(k) clearance record for CT PERFUSION 4, a class II device, cleared for GE Healthcare on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list 888 510(k) clearances for GE Healthcare, from to . As of , FDA records show one recall naming K052839.

Clearance record

Decision date
Received
(154 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
GE Healthcare 3000 N. Grandview Blvd., Waukesha WI
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code JAK

Trailing 12 months
21 clearances under product code JAK in the twelve months to October 2026, March 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code JAK, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 202610
April 20260
May 20261
June 20262
July 20262
August 20260
September 20264
October 20260