510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841996Substantially Equivalent

Maxicamera 400T W/body Contour Tomogra

General Electric Co., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841996 is the FDA 510(k) clearance record for MAXICAMERA 400T W/BODY CONTOUR TOMOGRA, a class I device, cleared for General Electric Co. on under FDA product code JAM (Scanner, Whole Body, Nuclear). FDA records list 256 510(k) clearances for General Electric Co., from to . As of , FDA records show no recalls naming K841996.

Clearance record

Decision date
Received
(61 days to decision)
Product code
JAM Scanner, Whole Body, Nuclear
Regulation
21 CFR 892.1330
Device class
Class I
Review panel
Radiology
Applicant
General Electric Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JAM

Trailing 12 months

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

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