# K052023: Cadimas Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Alan Penn & Associates., Inc.
- Decided: Dec 8, 2005 after 135 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913770 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043216: Cadstream Version 4.0, Confirma, Inc. (2005) Summary page 1.
- K050846: B-Cad System, Version 1.0, The Medipattern Corporation (2005) Summary page 1.
- K031350: 3TP Software Option, 3tp, LLC (2003) Summary page 1.

## Indications for use
CADimas VI.0 is indicated for processing of dynamic contrast enhanced MR images. CADimas VI.0 provides enhanced visualization for image interpretation.

Source page: https://510kreport.com/device/K052023
Methodology: https://510kreport.com/methodology