PedCAT 1000-115
PedCAT 1000-115 is a Class II device made by CurveBeam LLC, cleared under FDA 510(k) K113548 on 10 Apr 2012 and listed in FDA GUDID since 1 Aug 2017 (UDI-DI 00863152000300), 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 | Number00863152000300 | Date1 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113548 | Date10 Apr 2012 | StatusActive |
Official records
- AccessGUDID record 00863152000300
- FDA 510(k) database K113548
Across registries
- FDA 510(k) K113548 decided 10 Apr 2012 Active
- FDA GUDID UDI-DI 00863152000300 listed 1 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K113548
- Listed FDA GUDID 00863152000300
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PedCAT
- Generic name
- Limited-view-field CT system
- Model / reference
- 1000-115
- Primary DI / UDI-DI
- 00863152000300
- 510(k) Number
- FDA product code
- JAK
- GMDN term
- Limited-view-field CT system
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
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