Digisonics, Inc
Raleigh, NC, US
DIGISONICS, INC. appears in FDA device records in Raleigh, NC. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Digisonics, Inc between 1980 and 1997. The busiest year on record is 1980, with 1. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1990 | 1 |
| 1997 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1626313 | 1626313 | DIGISONICS, INC. | 305 Church at N Hills St, Raleigh, NC 27609 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2214-2023 | Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software | Software issue | Class II | Open, Classified | |
| Z-2193-2011 | 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-screen (2-D, M-Mode and Doppler) measurements of left ventricle, right ventricle, etc. | Left ventricle volume was inaccurate when the volumes were measured from images having different scales. | Terminated | ||
| Z-2180-2011 | 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 system with an associated clinical database. It provides capture, review, and storage of images together with report creation and data basing. | Data from one patient's study had the potential for being put into another patient's report. | Terminated | ||
| Z-2166-2011 | 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 capture, review and storage of images together with report creation and data basing. | Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed. | Terminated | ||
| Z-2066-2011 | 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 Digisonics OB-View/OB-Windows systems. | Data/measurements from a OB report sent from ultrasound systems populated the wrong OB-View report | Terminated | ||
| Z-2113-2011 | 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 fetal growth throughout the gestational period, which can help evaluate clinical situations. OB-View provides image management for the user to capture, view, read, and edit images. | Study would on occasion have fetal heart rate and/or cervical length on the report that was not entered nor did it belong to that patient. Software displayed incorrect data for fetal heart rate and cervical length in OB ultrasound reports. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain