4C-D
4C-D is a Class II device made by GE Parallel Design, Inc., cleared under FDA 510(k) K152567 on 6 Nov 2015 and listed in FDA GUDID since 15 Jul 2016 (UDI-DI 00840682105231), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 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 | Number00840682105231 | Date15 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152567 | Date6 Nov 2015 | StatusActive |
Official records
- AccessGUDID record 00840682105231
- FDA 510(k) database K152567
Across registries
- FDA 510(k) K152567 decided 6 Nov 2015 Active
- FDA GUDID UDI-DI 00840682105231 listed 15 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K152567
- Listed FDA GUDID 00840682105231
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Extracorporeal ultrasound imaging transducer, hand-held
- Model / reference
- 4C-D
- Primary DI / UDI-DI
- 00840682105231
- 510(k) Number
- FDA product code
- IYO, ITX, IYN
- GMDN term
- Extracorporeal ultrasound imaging transducer, hand-held
- Device class
- Class II
- Regulation number
- 892.1560, 892.1570, 892.1550
- GUDID distribution status
- Not in Commercial Distribution
Similar devices in this category
Other devices filed under Extracorporeal ultrasound imaging transducer, hand-held.
- 5C1 Transducer 11291794 by SIEMENS MEDICAL SOLUTIONS USA, INC.
- 6C1 Transducer 11503481 by SIEMENS MEDICAL SOLUTIONS USA, INC.
- CA431 9600177000 by Esaote S.p.A.
- IOT342 121201600 by Esaote S.p.A.
- C1-6-D by GE HEALTHCARE JAPAN CORPORATION
- C10-3 P23117-20A by Fujifilm Sonosite, Inc.
- SLAx/13-6 MHz P07699-71 by Fujifilm Sonosite, Inc.
- C253A 04573596214510 by FUJIFILM CORPORATION
- C1-6VN-D by GE HEALTHCARE JAPAN CORPORATION
- I12C5 transducer 9034 by Bk Medical ApS