CW Module Kit 115-024664-00
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
CW Module Kit 115-024664-00 is a Class II device made by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., cleared under FDA 510(k) K150204 on 10 Apr 2015 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 06944904053127), 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 | Number06944904053127 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK150204 | Date10 Apr 2015 | StatusActive |
Official records
- AccessGUDID record 06944904053127
- FDA 510(k) database K150204
Across registries
- FDA 510(k) K150204 decided 10 Apr 2015 Active
- FDA GUDID UDI-DI 06944904053127 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K150204
- Listed FDA GUDID 06944904053127
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CW Module Kit
- Generic name
- General-purpose ultrasound imaging system
- Model / reference
- 115-024664-00
- Primary DI / UDI-DI
- 06944904053127
- 510(k) Number
- FDA product code
- IYN
- GMDN term
- General-purpose ultrasound imaging system
- Device class
- Class II
- Regulation number
- 892.1550
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under General-purpose ultrasound imaging system.
- Versana Premier R2 VA by GE Medical Systems (China) Co., Ltd.
- ACUSON P500 Diagnostic Ultrasound System 10785577 by SIEMENS MEDICAL SOLUTIONS USA, INC.
- ACUSON Juniper Select Diagnostic Ultrasound System 11653093 by SIEMENS MEDICAL SOLUTIONS USA, INC.
- ExactVu High Resolution Micro-Ultrasound System 1.0 EV-SYS-220 by Exact Imaging
- Ultrasound System SONIMAGE HS1 AC7G by KONICA MINOLTA, INC.
- Diagnostic Ultrasound System Acclarix LX28 by Edan Instruments, Inc.
- CONTEC CMS1700C by Contec Medical Systems Co., Ltd.
- Ultrasound System SONIMAGE HS1 AC7J by KONICA MINOLTA, INC.
- SonoSite iViz P20830-15 by Fujifilm Sonosite, Inc.
- E-CUBE 8 by Alpinion Medical Systems Co., Ltd.
Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →