510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K851301Substantially Equivalent

Target Cat#b7850aa & B7850ab & B7850b

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

K851301 is the FDA 510(k) clearance record for TARGET CAT#B7850AA & B7850AB & B7850B, a class II device, cleared for General Electric Co. on under FDA product code LHN (System, Radiation Therapy, Charged-Particle, Medical). FDA records list 256 510(k) clearances for General Electric Co., from to . As of , FDA records show no recalls naming K851301.

Clearance record

Decision date
Received
(172 days to decision)
Product code
LHN System, Radiation Therapy, Charged-Particle, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
General Electric Co. P.O. Box 414, Milwaukee WI
Third party review
No

Clearances, product code LHN

Trailing 12 months
4 clearances under product code LHN in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LHN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260