ISOgray
by Dosisoft
Ref IS1001
ISOgray (IS1001) is a Class IIb device made by Dosisoft, registered in EUDAMED on 26 Nov 2021 (Basic UDI-DI B-+B501ISOGRAY0403010), active as of 24 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-+B501ISOGRAY0403010 +B501ISOGRAY0403010 | Date26 Nov 2021 | StatusActive |
Official records
- EUDAMED public site B-+B501ISOGRAY0403010
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / reference
- IS1001
- Primary DI / UDI-DI
- +B501ISOGRAY0403010
- Basic UDI-DI
- B-+B501ISOGRAY0403010
- EMDN code
- Z11010401 Radiotherapy treatment planning systems
- Device class
- Class IIb
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000014706
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