510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013561Substantially Equivalent

Lightspeed 4.0 CT Scanner System

GE Healthcare, New Berlin WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013561 is the FDA 510(k) clearance record for LIGHTSPEED 4.0 CT SCANNER SYSTEM, a class II device, cleared for GE Medical Systems 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 5 recalls naming K013561.

Clearance record

Decision date
Received
(13 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 Medical Systems 16800 Ryerson Rd., New Berlin WI
510(k) summary
Summary
Third party review
Yes

Clearances, product code JAK

Trailing 12 months
20 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 20263
October 20260