Elekta Unity
by Elekta Solutions Ab 2 variants
510(k) K223209
Elekta Unity is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Elekta Solutions Ab, cleared under FDA 510(k) K223209 on 23 Feb 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223209 | Date23 Feb 2023 | StatusActive |
Official records
- FDA 510(k) database K223209
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).
- VSS, VIRTUAL SIMULATION SYSTEM by Nucletron Corp.
- RPM RESPIRATORY GATING SYSTEM by Varian Medical Systems, Inc.
- LIAC by Sordina S.P.A.
- BEAMSCAN by Ptw-Freiburg Physikalisch Technische-Werksraetten
- SHADOW TRAYS by Mick Radio-Nuclear Instruments, Inc.
- PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP) by Philips Medical Systems
- Precise Bite™ MTCBPBITETD by Medtec LLC
- KLARITY MEDICAL R550-P3 by Klarity Medical Products, LLC
- T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 by Bionix Development Corp.
- System WingSTEP M Low P10107-755 by IT-V Medizintechnik GmbH