# K042225: Acmi Invisio Icn, Models Icn-0564 and Icn-0565

- Pathway: 510(k) (Special)
- Applicant: Acmi Corporation
- Decided: Sep 10, 2004 after 24 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931154 (1993). 16 ancestors in all.
101 later devices descend from it; 2 cite it directly.
2 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030960: Ecn Electronic Video Cystonephroscope, Acmi Corporation (2003) Summary page 1.

## Most influential descendants
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System (2006), 99 descendants of its own
- K131369: Flexible Video-Uretero-Renoscope System (2013), 53 descendants of its own
- K153049: LithoVue System (2015), 24 descendants of its own
- K172098: Medical Video Endoscope System (2017), 23 descendants of its own
- K072594: Gyrus Acmi Ipn-2505, Invisio  Smith Percutaneous  Nephroscope System (2007), 23 descendants of its own

## Indications for use
The ACMI® INVISIO ICN (ICN) Digital Flexible CystoNephroscope System (which includes the ICN scope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior ofrthe kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K042225
Methodology: https://510kreport.com/methodology