Atlantis Diagnostics Intl., Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Atlantis Diagnostics Intl., Inc. makes
Atlantis Diagnostics Intl., Inc. manufactures diagnostic ultrasound systems, including the ATLAS 2.0, ATLAS 1.0, and HDI 1000 models, which are used for medical imaging in clinical settings.
These devices are classified as Class II medical devices and are listed in the FDA’s 510(k) premarket notification database; the company is based in the United States.
Catalogue
- 510(k) 510(k)
Hdi 1000 Diagnostic Ultrasound System Ref K980860
510(k) 510(k)Atlas 1.0 Diagnostic Ultrasound System Ref K936067
510(k) 510(k)
Frequently asked questions
How many devices does Atlantis Diagnostics Intl., Inc. have in the registry?
The registry currently lists 3 devices for Atlantis Diagnostics Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Atlantis Diagnostics Intl., Inc.'s devices?
Among its 3 most recently registered devices, Atlantis Diagnostics Intl., Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Atlantis Diagnostics Intl., Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Atlantis Diagnostics Intl., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Atlantis Diagnostics Intl., Inc. in the registry?
The most recently registered devices listed for Atlantis Diagnostics Intl., Inc. include ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE), HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM and ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM.