# K203720: Micromate

- Pathway: 510(k) (Traditional)
- Applicant: Isys Medizintechnik GmbH
- Decided: Jun 22, 2021 after 183 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 K974513 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131433: Isys 1 (U.S),Accessory, Non-Sterile, Isys Medizintechnik GmbH (2014) Summary page 4.

## Most influential descendants
- K230130: Micromate™ Navi+ (2023), 0 descendants of its own

## Indications for use
The Micromate™ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the surgeon in the positioning of a needle or instrument where both computed tomography (CT) and fluoroscopic imaging can be used for target trajectory planning and intraoperative tracking. The needle or electrode is then manually advanced by the surgeon. Trajectory planning is made with software that is not part of the Micromate™ device

Source page: https://510kreport.com/device/K203720
Methodology: https://510kreport.com/methodology