510(k) · Hematology

LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer

by Bonraybio Co., Ltd.

LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer is an AI-enabled medical device from Bonraybio Co., Ltd. that the U.S. FDA cleared through 510(k) K202089 on October 28, 2020. Its lead review panel is Hematology and its primary product code is POV (Semen Analysis Device).

See also all FDA AI clearances in 2020, top hematology AI devices.

Key facts

Submission numberK202089
Pathway510(k)
Date of final decision
Company (FDA list)Bonraybio Co., Ltd.
Lead review panelHematology
Primary product codePOV — Semen Analysis Device
Applicant (openFDA)Bonraybio Co., Ltd.
Applicant locationTaichung, TW
Device classClass 2
Regulation number21 CFR 864.5220
Decision codeSESE
Submission typeSpecial

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer went through this pathway (K202089).

openFDA lists it as a Class 2 device under 21 CFR 864.5220. Class II devices are moderate risk and are subject to general and special controls.

Product code POV covers 5 devices on the FDA AI list. By decision date, this device is #2 of 5 under that code. Bonraybio Co., Ltd. has 4 AI-enabled devices on the list, and the Hematology panel accounts for 22 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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