Exablate 2100/2100 VI System

FDA premarket approval P110039/S008 · decided 2018-01-25

Approval details

PMA number

P110039

Supplement

S008

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Exablate 2100/2100 VI System

Generic name

Ablation system, high intensity focused ultrasound (HIFU), MR-guided

Applicant

Insightec

Date received

2017-09-22

Decision date

2018-01-25

Days to decision

125 days

Decision code

APPR

Product code

NRZ

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Tirat Carmel

Statement

Approval for 1) Software maintenance update to the currently approved clinical software (SW) Versions 6.24 (Windows-XP)/6.241 (Windows-7) used in the Exablate Model 2100/ 2100V1 Type 1.1 / Type 1.11 System (referred to as Exablate Bone or the system). The new software revision will be Version 6.57 (Windows-XP)/6.58 (Windows-7) (6.57 is a set of enhancements to the SW; 6.58 is an update to Windows 7 OS compatibility); and 2) Addition of a water bag as an accessory for acoustic coupling. The water