UBM Probe DGH1500
UBM Probe DGH1500 is a Class II device made by Dgh Technology Inc., cleared under FDA 510(k) K171301 on 31 Jul 2017 and listed in FDA GUDID since 5 Sep 2017 (UDI-DI 00857377006148), 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 | Number00857377006148 | Date5 Sep 2017 | StatusListed |
| United States | FDA 510(k) | NumberK171301 | Date31 Jul 2017 | StatusActive |
Official records
- AccessGUDID record 00857377006148
- FDA 510(k) database K171301
Across registries
- FDA 510(k) K171301 decided 31 Jul 2017 Active
- FDA GUDID UDI-DI 00857377006148 listed 5 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K171301
- Listed FDA GUDID 00857377006148
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- UBM Probe
- Generic name
- Ophthalmic ultrasound imaging transducer
- Model / reference
- DGH1500
- Primary DI / UDI-DI
- 00857377006148
- 510(k) Number
- FDA product code
- ITX, IYO
- GMDN term
- Ophthalmic ultrasound imaging transducer
- Device class
- Class II
- Regulation number
- 892.1570, 892.1560
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).
- DIAGNOSTIC ULTRASOUND IMAGING CATHETER by Boston Scientific
- BALLOON FOR ULTRASONIC ENDOSCOPES by N.M. Beale Co., Inc.
- RIC12-D 5918580 by GE Healthcare Austria GmbH & Co OG
- ATLANTIS PVIMAGING CATHETER, MODEL H749364560 by Boston Scientific
- PRAGER SHELL by Esi, Inc.
- Water Standoff Collar UA0671 by Bk Medical ApS
- Site Rite 9000012 by Bard Access Systems, Inc.
- ALOKA LISENDO 880 by FUJIFILM CORPORATION
- Diagnostic Ultrasound System Acclarix LX3 Super by Edan Instruments, Inc.
- Non-implantable, needle guide, reusable UA1239 by Bk Medical ApS