# K214125: TRANBERG Thermoguide Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Laserthermia Systems, AB
- Decided: Sep 22, 2022 after 266 days
- Product code: ONO (Neurosurgical Laser With Mr Thermography)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913475 (1991). 13 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181859: Visualase Thermal Therapy System, Medtronic Navigation, Inc. (2019) Summary page 4.

## Most influential descendants
- K231061: NeuroBlate System (2023), 6 descendants of its own
- K240877: Monteris Medical NeuroBlate System (2024), 5 descendants of its own
- K260976: NeuroBlate System (2026), 1 descendant of its own
- K250307: Visualase V2 MRI-guided Laser Ablation System (9736422) (2025), 1 descendant of its own
- K262315: NeuroBlate System (2026), 0 descendants of its own

## Indications for use
The TRANBERG®|Thermoguide Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in neurosurgery, for a wavelength of 1064nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the TRANBERG®|Thermoguide therapy system can process images using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time. The TRANBERG®|Thermoguide Therapy System is compatible with the following 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of analysis using the TRANBERG®|Thermoguide Therapy System.

Source page: https://510kreport.com/device/K214125
Methodology: https://510kreport.com/methodology