EV9C Transrectal Transducer
EV9C Transrectal Transducer (EV-9C) is a Class II device made by Exact Imaging, cleared under FDA 510(k) K162972 on 2 Dec 2016 and listed in FDA GUDID since 8 Feb 2017 (UDI-DI 00628055481041), active as of 21 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 | Number00628055481041 | Date8 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162972 | Date2 Dec 2016 | StatusActive |
Official records
- AccessGUDID record 00628055481041
- FDA 510(k) database K162972
Across registries
- FDA 510(k) K162972 decided 2 Dec 2016 Active
- FDA GUDID UDI-DI 00628055481041 listed 8 Feb 2017 Listed
Timeline
- Cleared FDA 510(k) K162972
- Listed FDA GUDID 00628055481041
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Rectal/vaginal ultrasound imaging transducer
- Model / Ref / Catalog
- EV9C, EV-9C
- Primary DI / UDI-DI
- 00628055481041
- 510(k) Number
- FDA product code
- ITX
- GMDN term
- Rectal/vaginal ultrasound imaging transducer
- Device class
- Class II
- Regulation number
- 892.1570
- GUDID distribution status
- In Commercial Distribution
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