# K153023: Ablatherm Integrated Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Edap Technomed, Inc.
- Decided: Nov 6, 2015 after 22 days
- Product code: PLP (High Intensity Ultrasound System For Prostate Tissue Ablation)
- Device class: 2
- Regulation: 21 CFR 876.4340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN150011 (2015). 1 ancestor in all.
7 later devices descend from it; 3 cite 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)
- DEN150011: Sonablate 450, Sonacare Medical, LLC (2015) Summary page 4.

## Most influential descendants
- K191200: TULSA-PRO System (2019), 3 descendants of its own
- K172721: Focal One (2018), 1 descendant of its own
- K251910: Focal One® (2025), 0 descendants of its own
- K230692: TULSA-PRO System (2023), 0 descendants of its own
- K211858: TULSA-PRO System (2022), 0 descendants of its own

## Recalls of this device
- Aug 14, 2017 · Class II · Z-0049-2018: The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining devices in the U.S. unt

## Indications for use
The Ablatherm® Integrated Imaging device is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue.

Source page: https://510kreport.com/device/K153023
Methodology: https://510kreport.com/methodology