Beluga1

FDA UDI

Class II (US FDA UDI)

by Tissue Differentiation Intelligence LLC

Identity

Trade Name: Beluga1 FDA UDI
Generic Name: Surgical ultrasound imaging transducer FDA UDI
Device Name: Beluga1 Imaging Probe FDA UDI
Model / Reference: 100005 FDA UDI
Description: Beluga1 Imaging Probe FDA UDI

Identifiers

Primary DI / UDI-DI: 00860001239348 FDA UDI
510(k) Number: K192388 FDA UDI
FDA Product Code: ITX FDA UDI
GMDN Term: Surgical ultrasound imaging transducer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 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

Yes

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

Sterilization Method

Hydrogen Peroxide FDA UDI

Category: Surgical ultrasound imaging transducer

Beluga1 by Tissue Differentiation Intelligence LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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7LT4 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
HUMANSCAN — Humanscan Company, Ltd. · Class II

Cleared under the same submission

K192388 also covers:

SonoVision — Tissue Differentiation Intelligence LLC

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: Tissue Differentiation Intelligence LLC

Sources (1)

FDA UDI 75998864-3e1b-4ebb-b99d-bdc3af3d8109 36 fields · synced Jun 1, 2026