Klarity SGRT System (ARSG-E1A, ARSG-E3A)

FDA 510(k) K241937 · Klarity Medical & Equipment (GZ) Co., Ltd.

Substantially Equivalent

510(k) numberK241937

Submission

Device name
Klarity SGRT System (ARSG-E1A, ARSG-E3A)
Applicant
Klarity Medical & Equipment (GZ) Co., Ltd.
Guangzhou, CN
Received
July 2, 2024
Decision date
March 18, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

Other 510(k)s with product code IYE

510(k)DeviceApplicantDecision
K261718EZFluence (RADEZ V2)IYE · Traditional Radformation, Inc.08/31/2026SE
K260733MRIA Radiation Therapy Information System (MRIA)IYE · Traditional Manteia Technologies Co., Ltd.08/26/2026SE
K261856Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional Varian Medical Systems, Inc.08/03/2026SE
K252937ThinkQA 3IYE · Traditional Dosisoft SA06/12/2026SE
K253004Luna 3DIYE · Traditional Lap GmbH Laser Applikationen06/04/2026SE
K260792AerFrame Patient Immobilization System (AFPIS)IYE · Traditional Stabilix, LLC05/08/2026SE
K252258Veriqa RT Epid 3DIYE · Traditional Ptw-Freiburg Physikalisch-Technische-Werkstaetten…04/15/2026SE
K253962ClearCheck (RADCC V2.7)IYE · Traditional Radformation, Inc.04/03/2026SE
K253012AlignRT Plus (8.0)IYE · Traditional Vision Rt, Ltd.03/18/2026SE
K252977Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional Varian Medical Systems, Inc.01/21/2026SE

More from Varian Medical Systems, Inc.

510(k)DeviceDecision
K220539Klarity SRS Baseplate, Klarity Promise BaseplateIYE · Traditional 11/01/2022SE
K202747Klarity BolusIYE · Traditional 05/14/2021SE

Questions and answers

When was Klarity SGRT System (ARSG-E1A, ARSG-E3A) cleared by the FDA?

Klarity SGRT System (ARSG-E1A, ARSG-E3A) (K241937) received a 510(k) decision of Substantially Equivalent on March 18, 2025, 259 days after the submission was received.

What is the product code of K241937?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.