Intl. Acoustics, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Intl. Acoustics, Inc. makes
Intl. Acoustics, Inc. manufactures ultrasound-based diagnostic systems, including the DS-II Digital Sonography System for imaging and the DSP100 Carotid Phonoangiography Module for vascular assessments. The company also provides specialized amplifier hardware, such as the DSP100 Amplifier and its modified version, alongside software solutions like the IAI Program-Computer program for ultrasound data processing.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II medical devices. These systems are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Ds-Ii Digital Sonography System Ref K864278
Regimes: 510(k) Registry: 510(k)DSP100 Carotid Phonoangiography Module Ref K864429
Regimes: 510(k) Registry: 510(k)Iai Program-Computer Program Ref K844997
Regimes: 510(k) Registry: 510(k)DSP100 Amplifier Ref K860814
Regimes: 510(k) Registry: 510(k)Modified DSP100 Amplifier Ref K873640
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Intl. Acoustics, Inc. have in the registry?
The registry currently lists 5 devices for Intl. Acoustics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intl. Acoustics, Inc.'s devices?
Among its 5 most recently registered devices, Intl. Acoustics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Intl. Acoustics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Intl. Acoustics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Intl. Acoustics, Inc. in the registry?
The most recently registered devices listed for Intl. Acoustics, Inc. include DS-II DIGITAL SONOGRAPHY SYSTEM, DSP100 CAROTID PHONOANGIOGRAPHY MODULE, IAI PROGRAM-COMPUTER PROGRAM and DSP100 AMPLIFIER.