510(k) clearance

PV-iCurve Pro

FDA 510(k) source

510(k) number

K261531

Applicant

Perception Vision Medical Technology Co., Ltd.

Decision date

Oct 21, 2026

Date received

May 8, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LLZ

Device type

System, Image Processing, Radiological

Device class

Class II

Regulation

21 CFR 892.2050

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Guangzhou, CN