510(k) K970402 ยท LLZ System, Image Processing, Radiological
DOCTORS REVIEW SYSTEM
| Applicant | Digisonics, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Mar 26, 1997 |
| Received | Feb 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970402
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.