# K112692: Identify

- Pathway: 510(k) (Traditional)
- Applicant: Humediq GmbH
- Decided: Aug 3, 2012 after 323 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K003285 (2001). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062611: Iguide System, Medical Intelligence Medizintechnik-GmbH-An Elekta (2006) Summary page 1.

## Most influential descendants
- K190137: Identify (2019), 5 descendants of its own
- K192968: Identify (2019), 4 descendants of its own
- K210835: Identify (2021), 3 descendants of its own
- K230576: Identify (2023), 2 descendants of its own
- K242957: Identify (4.0) (2025), 1 descendant of its own

## Indications for use
The intended use of the device is to identify the patient and patient specific accessories and to guide the positioning of patients and accessories for radiosurgery or radiotherapy procedures. The system uses optical tracking of optical markers and RFID tracking of RFID tags as the method of identifying the patient and the accessories. The system consists of an optical tracking system with optical markers and RFID tracking system including RHID tags, a RHID identification system, a computer workstation, an interlock unit, a handheld controller, Wireless LAN access points, a video camera and calibration tools. The only location where the device is used is the radiologic diagnostic and radiation therapy department.

Source page: https://510kreport.com/device/K112692
Methodology: https://510kreport.com/methodology