510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K973441Substantially Equivalent

Leksell Gammaplan

Patterson Consulting Group, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973441 is the FDA 510(k) clearance record for LEKSELL GAMMAPLAN, a class II device, cleared for Patterson Consulting Group, Inc. on under FDA product code IWB (System, Radiation Therapy, Radionuclide). FDA records list one 510(k) clearance for Patterson Consulting Group, Inc. As of , FDA records show 4 recalls naming K973441.

Clearance record

Decision date
Received
(202 days to decision)
Product code
IWB System, Radiation Therapy, Radionuclide
Regulation
21 CFR 892.5750
Device class
Class II
Review panel
Radiology
Applicant
Patterson Consulting Group, Inc. 181 40 Smokesignal Dr., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code IWB

Trailing 12 months

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

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