Base Ten Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Base Ten Systems, Inc. makes
Base Ten Systems, Inc. manufactures the PRENVAL I, a device designed for prenatal ultrasound imaging, and the UPACS software, including its Version 1.7 update, which supports automated fetal cardiac analysis and measurement. These tools are intended for use in obstetric ultrasound examinations to assess fetal development and cardiac function.
The company’s products are classified as Class I medical devices under FDA regulations and are authorised through the 510(k) clearance process. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with applicable US regulatory requirements. The company operates from the United States.
Catalogue
Prenval I Ref K953652
Regimes: 510(k) Registry: 510(k)Upacs Ref K960941
Regimes: 510(k) Registry: 510(k)Upacs Version 1.7 Ref K961160
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Base Ten Systems, Inc. have in the registry?
The registry currently lists 3 devices for Base Ten Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Base Ten Systems, Inc.'s devices?
Among its 3 most recently registered devices, Base Ten Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Base Ten Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Base Ten Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Base Ten Systems, Inc. in the registry?
The most recently registered devices listed for Base Ten Systems, Inc. include PRENVAL I, UPACS and UPACS VERSION 1.7.