Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032638959

FEI Number

3032638959

Entity Name

Elekta Inc.

City/State/Country

San Jose, CA, US

Establishment Address

101 Nicholson Ln, San Jose, CA 95134, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ELEKTA AB (Owner Number: 8030893)

Owner / Operator Contact Address

Hagaplan 4, Stockholm, SE-AB SE11368, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Xoft Axxent Electronic Brachytherapy System Model 110 Xoft Axxent Cervical Applicators Xoft Axxent Electronic Brachytherapy System Axxent Balloon Applicator, Model Ab2034, Ab2045, Ab2056, Ab2057e, Ab2067e Axxent Flexishield Mini Axxent Surface Applicator, Model 710257 Axxent Cervical Applicator Axxent Radiation Shield - Rigid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2024-12-13
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2024-12-13
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2024-12-13
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2024-12-13
IXI	Block, Beam-Shaping, Radiation Therapy	Radiology	Class 2	892.5710	2024-12-13
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2024-12-13
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2024-12-13
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2024-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ELEKTA AB

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9617016	ELEKTA LIMITED	CRAWLEY West Sussex, GB
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
3009894282	ELEKTA BEIJING MEDICAL SYSTEMS CO., LTD	Beijing, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241174	Carl Zeiss Meditec, AG	INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)	2025-01-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2018	Carl Zeiss Meditec AG Rudolf-Eber-Str. 11 Oberkochen Germany	2	Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments

Similar Registrations

Registration Number	Establishment Name	Location
3036107971	VOXEL RAY SOLUTIONS, LLC	Burr Ridge, IL, US
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
3030230020	KOPLAK CORP	Sunrise, FL, US
9615010	CARL ZEISS MEDITEC AG (OBERKOCHEN)	OBERKOCHEN Baden-Wurttemberg, DE
9611894	NUCLETRON B.V.	VEENENDAAL Utrecht, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032638959. Last updated year: 2026. Please use registration number 3032638959 when referencing this establishment in official correspondence.