Contract manufacturerElekta Inc. (San Jose, CA)CaliforniaRadiologyClass II
Elekta Inc.
Contract manufacturer · San Jose, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3032638959 (openFDA record; or search FDA's registration database)
- FEI number
- 3032638959
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- ELEKTA AB (FDA owner/operator no. 8030893)
- Registered address
- 101 Nicholson Ln, San Jose, CA 95134
- Contract listings
- 10 device listings, 3 product codes, first listed Dec 13, 2024
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| IXI | Block, Beam-Shaping, Radiation Therapy | Class II | Radiology | Contract manufacturing | Dec 13, 2024 |
| JAD | System, Therapeutic, X-Ray | Class II | Radiology | Contract manufacturing | Dec 13, 2024 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | Class II | Radiology | Contract manufacturing | Dec 13, 2024 |