Ivos

FDA UDI

Class II (US FDA UDI)

by HAMILTON THORNE, Inc.

Identity

Trade Name: IVOS FDA UDI
Generic Name: Spermatozoa/semen analyser IVD FDA UDI
Device Name: A self-contained computerized optical analyzer used for evaluation of sperm samples. It will provide concentration, velocity, morph and motion parameters, which aid the clinician in evaluation of semen quality. FDA UDI
Model / Reference: IVOS FDA UDI
Description: A self-contained computerized optical analyzer used for evaluation of sperm samples. It will provide concentration, velocity, morph and motion parameters, which aid the clinician in evaluation of semen quality. FDA UDI

Identifiers

Primary DI / UDI-DI: 00858604006108 FDA UDI
510(k) Number: K920719 FDA UDI
FDA Product Code: GKL FDA UDI
GMDN Term: Spermatozoa/semen analyser IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Spermatozoa/semen analyser IVD

Ivos by HAMILTON THORNE, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spermatozoa/semen analyser IVD.

SQA-Vision Sperm Quality Analyzer — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. · Class II
Unitron — Unitron Hearing · Class II
SQA-iO Sperm Quality Analyzer — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. · Class II
SQA-iOw Sperm Quality Analyzer — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. · Class II
LensHooke Semen Analysis System — BONRAYBIO CO., LTD. · Class II
Unitron — Unitron Hearing · Class II
LensHooke Semen Quality Analyzer — BONRAYBIO CO., LTD. · Class II
SQA-V Sperm Quality Analyzer — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. · Class II

Cleared under the same submission

K920719 also covers:

CEROS — HAMILTON THORNE, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: HAMILTON THORNE, Inc.

Sources (1)

FDA UDI 9e1ebb66-302a-40af-a0b7-8134d22d9364 34 fields · synced May 30, 2026