PedCAT 1000-230
PedCAT 1000-230 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 00863152000317), 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 | Number00863152000317 | Date1 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113548 | Date10 Apr 2012 | StatusActive |
Official records
- AccessGUDID record 00863152000317
- FDA 510(k) database K113548
Across registries
- FDA 510(k) K113548 decided 10 Apr 2012 Active
- FDA GUDID UDI-DI 00863152000317 listed 1 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K113548
- Listed FDA GUDID 00863152000317
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- Withdrawn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
- 1000-230
- Primary DI / UDI-DI
- 00863152000317
- 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
Similar devices
Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).
- PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 by Philips Medical Systems (Cleveland), Inc.
- AQUILION PRIME, V6.00 by Toshiba Medical Systems
- AQUILION ONE VISION, V6.0 by Toshiba Medical Systems
- LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM by GE MEDICAL SYSTEMS, INC.
- Ablation Confirmation by NeuWave Medical, Inc.
- CT HILIGHT ADVANTAGE by GE MEDICAL SYSTEMS, INC.
- syngo.CT Skull Unfolding by SIEMENS MEDICAL SOLUTIONS USA, INC.
- SCENARIA Phase 3 Whole-body X-ray CT System by Hitachi Medical Systems America, Inc.
- SOMATOM SCOPE/SOMATOM SCOPE POWER by SIEMENS MEDICAL SOLUTIONS USA, INC.
- SYNGO CT ONCOLOGY SOFTWARE PACKAGE by Siemens AG