An assembly of electrically-powered devices designed to treat solid tumours of hard (bone) and/or soft tissue [e.g., liver, kidney, breast, prostate] and/or gynaecological disorders (e.g., uterine fibroid, adenomyosis) through noninvasive or non-surgically inv
| Company | Devices | Share |
|---|---|---|
| Insightec Ltd | 78 | 53% |
| Profound Medical Inc | 58 | 39% |
| Histosonics, Inc. | 11 | 7% |
| Focus Surgery Inc | 1 | 1% |
Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| POH | Mr-Guided Focused Ultrasound System | 62 |
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablatio | 57 |
| NRZ | Ablation System, High Intensity Focused Ultrasound (Hifu), M | 15 |
| LSY | Ultrasound,Hyperthermia, Cancer Treatment | 14 |
| QGM | Ultrasound Histotripsy System | 8 |
| QND | Ablation System, High Intensity Focused Ultrasound (Hifu), M | 4 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
148 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Therapeutic oncological/gynaecological ultrasound system", from 4 companies. The largest labeler is Insightec Ltd with 53% of records.
POH (Mr-Guided Focused Ultrasound System), PLP (High Intensity Ultrasound System For Prostate Tissue Ablatio), NRZ (Ablation System, High Intensity Focused Ultrasound (Hifu), M), LSY (Ultrasound,Hyperthermia, Cancer Treatment)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.