510(k) K253078

Device
ART.1-US
Applicant
Seetreat Pty, Ltd.
510(k) number
K253078
Product code
MUJ
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-14
Date received
2025-09-23
Regulation
892.5050
Classification name
System, Planning, Radiation Therapy Treatment
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Eric Qin
Address
320 Pitt St. Sydney AU 2000 2000

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MUJ

510(k)DeviceApplicantDecision date
K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.2026-03-18
K260308TrueFit BolusAdaptiiv Medical Technologies, Inc.2026-02-19
K252002Monaco RTP System (6.3)Elekta Solutions AB2026-02-19
K253091ART-Plan+ (v3.1.0)Therapanacea Sas2025-12-23
K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)2025-12-22
K252863ClearCalc Model RADCA V2.6Radformation, Inc.2025-12-19
K250963PlanOne 1Cosylab Jsc, Control System Laboratory2025-11-20
K250064Dose+ (1.0)Mvision AI OY2025-09-04
K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RTBrainlab AG2025-06-17
K242992RayCare (2024A SP1)RaySearch Laboratories AB (PUBL)2025-04-17
K242748OncospaceOncospace, Inc.2025-04-11
K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3RaySearch Laboratories AB (PUBL)2025-04-04
K242822ART-Plan+ (v.3.0.0)Therapanacea Sas2025-02-25
K242463ARIA Radiation Therapy Management System (18.1)Varian Medical Systems, Inc.2024-12-13
K242378Eclipse Treatment Planning System (18.1)Varian Medical Systems2024-12-11