CT Scanner Tsx-501R
by Canon Inc.
CT Scanner Tsx-501R is a Class II device made by Canon Inc., cleared under FDA 510(k) K243398 on 20 Jun 2025 and listed in FDA GUDID since 1 Mar 2026 (UDI-DI 04987670104701), 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 | GUDID listing | Number04987670104701 | Date1 Mar 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243398 | Date20 Jun 2025 | StatusActive |
Official records
- AccessGUDID record 04987670104701
- FDA 510(k) database K243398
Across registries
- FDA 510(k) K243398 decided 20 Jun 2025 Active
- FDA GUDID UDI-DI 04987670104701 listed 1 Mar 2026 Listed
Timeline
- Cleared FDA 510(k) K243398
- Listed FDA GUDID 04987670104701
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CT Scanner
- Generic name
- Full-body CT system
- Model / reference
- TSX-501R
- Primary DI / UDI-DI
- 04987670104701
- 510(k) Number
- FDA product code
- JAK
- GMDN term
- Full-body CT system
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
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