Hd-307-10
Hd-307-10 is a Class II device made by Koven Technology, Inc., cleared under FDA 510(k) K912409 on 23 Dec 1991 and listed in FDA GUDID since 24 Feb 2016 (UDI-DI 00894912002111), 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 | Number00894912002111 | Date24 Feb 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK912409 | Date23 Dec 1991 | StatusActive |
Official records
- AccessGUDID record 00894912002111
- FDA 510(k) database K912409
Across registries
- FDA 510(k) K912409 decided 23 Dec 1991 Active
- FDA GUDID UDI-DI 00894912002111 listed 24 Feb 2016 Listed
Timeline
- Cleared FDA 510(k) K912409
- Listed FDA GUDID 00894912002111
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hd-307
- Generic name
- Vascular ultrasound system control unit
- Model / Ref / Catalog
- HD-307-10, HD-307
- Primary DI / UDI-DI
- 00894912002111
- 510(k) Number
- FDA product code
- JOP
- GMDN term
- Vascular ultrasound system control unit
- Device class
- Class II
- Regulation number
- 870.2880
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code JOP (Transducer, Ultrasonic).
- ACUSON S319 TRANSDUCER by Acuson Computed Sonography
- SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8 by Advanced Technology Laboratories, Inc.
- VASCULAR RECORDER #301 by Imex Medical Systems, Inc.
- 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA by Ausonics Pty, Ltd.
- MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417 by Hoffrel Instruments, Inc.
- Q-DOP by Quinton, Inc.
- VasoGuard (V10, V8, V6, V4, V2) by Corvascular Diagnostics, LLC
- UST-2266U-5 CW DOPPLER TRANSDUCER by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- MINI-DOPPLER ES-100 by Hayashi Denki Co., Ltd.
- 3MHZ ANNULAR ARRAY by Philips Ultrasound LLC