xCAT IQ 11020
xCAT IQ 11020 is a Class II device made by Xoran Technologies, LLC, cleared under FDA 510(k) K061834 on 7 Aug 2006 and listed in FDA GUDID since 17 Jun 2019 (UDI-DI 00860290000360), 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 | Number00860290000360 | Date17 Jun 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061834 | Date7 Aug 2006 | StatusActive |
Official records
- AccessGUDID record 00860290000360
- FDA 510(k) database K061834
Across registries
- FDA 510(k) K061834 decided 7 Aug 2006 Active
- FDA GUDID UDI-DI 00860290000360 listed 17 Jun 2019 Listed
Timeline
- Cleared FDA 510(k) K061834
- Listed FDA GUDID 00860290000360
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- xCAT IQ
- Generic name
- Cone beam computed tomography system, head/neck
- Model / reference
- 11020
- Primary DI / UDI-DI
- 00860290000360
- 510(k) Number
- FDA product code
- IZL
- GMDN term
- Cone beam computed tomography system, head/neck
- Device class
- Class II
- Regulation number
- 892.1720
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code IZL (System, X-Ray, Mobile).
- G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS by Electromek Diagnostic Systems, Inc.
- PORTA. X-RAY UNIT FP220 SCM-1-ETC, by Showa X-Ray Co., Ltd.
- MOBILE X-RAY UNIT by Ziehm International, Inc.
- DRX-Rise Mobile X-ray System 8626004 by CARESTREAM HEALTH, INC.
- GENERAL ELECTRIC AMX 110, AMX II AND AMX 3 by Pro-Tronics, Inc.
- MOBILETT MIRA by SIEMENS MEDICAL SOLUTIONS USA, INC.
- AMX-4 PLUS MOBILE X-RAY SYSTEM by GE MEDICAL SYSTEMS, INC.
- Optima XR200amx, Optima XR220amx by GE Medical Systems, LLC
- 510 CARBINETTE X-RAY UNIT by General X-Ray, Inc.
- RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT by Lorad Medical Systems, Inc.