# K132108: MAXIO

- Pathway: 510(k) (Traditional)
- Applicant: Perfint Healthcare Pvt, Ltd.
- Decided: May 19, 2014 after 315 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001284 (2000). 4 ancestors in all.
27 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060903: IG4 Image Guided System, Veran Medical Technologies, Inc. (2006) Summary page 1.
- K974513: Pinpoint, Philips Medical Systems (Cleveland), Inc. (1998) Summary page 1.

## Most influential descendants
- K150313: Ablation Confirmation (2015), 16 descendants of its own
- K202297: Aline Ablation Intelligence (2020), 11 descendants of its own
- K220256: MIM-Ablation (2022), 4 descendants of its own
- K191332: XACT Robotic System (2019), 3 descendants of its own
- K161285: Ablation Confirmation (2016), 3 descendants of its own

## Indications for use
MAXIO™ is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments during Computed Tomography (CT) guided percutaneous procedures. MAXIO™ permits physician verification of patient position prior to needle advancement and monitoring of respiratory levels during the procedure. Image registration and overlay tools available in MAXIO™ are intended to provide guidance to the user during planning and instrument placement. MAXIO™ is indicated for use with rigid straight instruments such as needles and probes used in Computed Tomography (CT) guided percutaneous interventional procedures performed by physicians trained for CT procedures on organs and anatomical structures in the thorax, abdomen and pelvis.

Source page: https://510kreport.com/device/K132108
Methodology: https://510kreport.com/methodology