FDA 510(k)

UltraGuideCTR® image guided soft tissue release system

Номер K: K252594 · 2025-09-29

ЗаявительSonex Health

Дата решения2025-09-29

Код продуктаHRX

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

UltraGuideCTR® image guided soft tissue release system is the device name listed in this FDA 510(k) record. The listed applicant is Sonex Health. It received FDA 510(k) clearance on 2025-09-29 under 510(k) number K252594. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the UltraGuideCTR® image guided soft tissue release system?

UltraGuideCTR® image guided soft tissue release system is a medical device that received FDA 510(k) clearance on 2025-09-29. The listed applicant is Sonex Health. The 510(k) number is K252594.

When did UltraGuideCTR® image guided soft tissue release system receive FDA 510(k) clearance?

UltraGuideCTR® image guided soft tissue release system received FDA 510(k) clearance on 2025-09-29, under 510(k) number K252594.

Who is the listed applicant for UltraGuideCTR® image guided soft tissue release system?

The FDA 510(k) record lists Sonex Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraGuideCTR® image guided soft tissue release system?

The FDA product code for UltraGuideCTR® image guided soft tissue release system is HRX.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: HRX)

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC K253523Freedom DS™ Decompression SystemSpinal Simplicity K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.