Indec Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Indec Systems, Inc. makes
Indec Systems, Inc. manufactures intravascular ultrasound (IVUS) imaging enhancers, including tools designed to improve vascular visualization and plaque characterization. Their portfolio includes contrast agents like ECHOPLAQUE for ultrasound studies and software upgrades such as IVUS PLUS for enhanced diagnostic capabilities in cardiac and peripheral vascular procedures.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Ivus Enhancer Ref K062985
Regimes: 510(k) Registry: 510(k)Echoplaque Ref K092842
Regimes: 510(k) Registry: 510(k)Ivus Plus Ref K024103
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Indec Systems, Inc. have in the registry?
The registry currently lists 3 devices for Indec Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Indec Systems, Inc.'s devices?
Among its 3 most recently registered devices, Indec Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Indec Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Indec Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Indec Systems, Inc. in the registry?
The most recently registered devices listed for Indec Systems, Inc. include IVUS ENHANCER, ECHOPLAQUE and IVUS PLUS.