Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015621321

FEI Number

3015621321

Entity Name

Akesis Inc.

City/State/Country

Concord, CA, US

Establishment Address

5129 Commercial Circle, Concord, CA 94520, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Akesis Inc (Owner Number: 10088577)

Owner / Operator Contact Address

5129 Commercial Circle, Concord, CA 94520, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203146

PMA Number

N/A

All Registered Proprietary Names

Galaxy RTx Gemini360RT X/Gamma Ray Integrated Digital Radiotherapy System Galaxy RTi

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWB	System, Radiation Therapy, Radionuclide	Radiology	Class 2	892.5750	2023-08-18
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-01-11
IWB	System, Radiation Therapy, Radionuclide	Radiology	Class 2	892.5750	2024-01-11
IWB	System, Radiation Therapy, Radionuclide	Radiology	Class 2	892.5750	2023-08-18

Official Correspondent

Lien Pham

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Akesis Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

Similar Registrations

Registration Number	Establishment Name	Location
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
3005136058	MASEP MEDICAL SCIENCE & TECHNOLOGY DEVELOPMENT(SHENZHEN)Co.	SHENZHEN Guangdong, CN
3014273653	XCISION MEDICAL SYSTEMS, LLC	Columbia, MD, US
3006946288	Best Theratronics Ltd.	Kanata Ontario, CA
9617016	ELEKTA LIMITED	CRAWLEY West Sussex, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015621321. Last updated year: 2026. Please use registration number 3015621321 when referencing this establishment in official correspondence.