Class Class II
iTFlow (K222854)
Description
iTFlow by Cardio Flow Design, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222854
Clearance Date2023-05-12
Clearance TypeTraditional
Product CodeLLZ
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222854
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. iTFlow (K222854) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141480 | CVI42 | Circle Cardiovascular Imaging, Inc. | 2014 |
| K082628 | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 | Circle Cardiovascular Imaging, Inc. | 2008 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240385 | VINT | Mediimg Corporation | 2024 |
Trace the full predicate network for K222854
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.