# K230130: Micromate™ Navi+

- Pathway: 510(k) (Traditional)
- Applicant: Isys Medizintechnik GmbH
- Decided: Oct 10, 2023 after 266 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: 3 generations back to K974513 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203720: Micromate, Isys Medizintechnik GmbH (2021) Summary page 4.

## Indications for use
The Micromate™ Navi+ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the user in the positioning of 8–19 gauge needles in the chest, abdomen and musculoskeletal structures when computed tomography (CT) optical navigation can be used for target trajectory planning and intra-operative tracking. The needle is then manually advanced by the user. Trajectory planning is made with software that is a part of the Micromate™ Navi+ device.

Source page: https://510kreport.com/device/K230130
Methodology: https://510kreport.com/methodology