Company ยท US
Digisonics, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1997. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2023 | Digisonics, Inc Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software Open, Classified |
LLZ | K970402 |
| May 13, 2011 | Digisonics, Inc Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098, Tel: (800) 940-3240, Fax: (713) 529-7999
Software used to make on-scr Terminated |
LLZ | K970402 |
| May 10, 2011 | Digisonics, Inc DigiView software release 3.4.4.4 through 3.5.5.2. , 2008 Digisonics, Inc, 800-940-3240.
Digiview is a digital image management and reporting system with an associated clinical database. It provides Terminated |
LLZ | K970402 |
| May 10, 2011 | Digisonics, Inc Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098, 800-940-3240.
DigiView is a digital image management and reporting Terminated |
LLZ | K970402 |
| Apr 29, 2011 | Digisonics, Inc Doctors Review System, OB-Windows/OB-View software release numbers 4.1 through 4.1.3, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098
OB-Windows provides professional reporting and analysis of Terminated |
LLZ | K970402 |
| Apr 26, 2011 | Digisonics, Inc OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098
OBLink provides automated transmission of patient data and measurements from ultrasound systems directly to D Terminated |
HEM | None listed |