# K131433: Isys 1 (U.S),Accessory, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Isys Medizintechnik GmbH
- Decided: Mar 11, 2014 after 298 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: 1 generation back to K974513 (1998). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974513: Pinpoint, Philips Medical Systems (Cleveland), Inc. (1998) Summary page 8.

## Most influential descendants
- K191332: XACT Robotic System (2019), 3 descendants of its own
- K201586: XACT Robotic System (2020), 2 descendants of its own
- K203720: Micromate (2021), 1 descendant of its own
- K230130: Micromate™ Navi+ (2023), 0 descendants of its own
- K213759: XACT Robotic System, ACE Model (2022), 0 descendants of its own

## Indications for use
The iSYS | 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 electrode 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 iSYS device.

Source page: https://510kreport.com/device/K131433
Methodology: https://510kreport.com/methodology