Ellex, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Ellex, Inc. makes
Ellex, Inc. manufactures diagnostic ultrasound systems, including the I3 System for abdominal imaging, and advanced imaging devices such as the Eye Cubed V4 for ophthalmic applications.
These products are classified as Class II medical devices and are authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
I3 System-Abd Diagnostic Ultrasound Ref K103608
Regimes: 510(k) Registry: 510(k)Ellex Innovative Imaging Eye Cubed V4 Ref K083061
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Ellex, Inc., initiated on 2007-09-25. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 25 Sep 2007 Z-0148-2008 Unclassified (pre-2012) Terminated Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations.
Full distribution text
- 25 Sep 2007 Z-0148-2008 Unclassified (pre-2012) Terminated Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations.
Frequently asked questions
How many devices does Ellex, Inc. have in the registry?
The registry currently lists 2 devices for Ellex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ellex, Inc.'s devices?
Among its 2 most recently registered devices, Ellex, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ellex, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ellex, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ellex, Inc.?
FDA recall records list 1 recall initiated by Ellex, Inc., the most recent initiated on 2007-09-25. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ellex, Inc. in the registry?
The most recently registered devices listed for Ellex, Inc. include I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND and ELLEX INNOVATIVE IMAGING EYE CUBED V4.