ArcScan Insight 100

FDA UDI

Class II (US FDA UDI)

by Arcscan, Inc.

Identity

Trade Name: ArcScan Insight 100 FDA UDI
Generic Name: Ophthalmic ultrasound imaging system FDA UDI
Model / Reference: AS100 FDA UDI

Identifiers

Catalog Number: AS100-120 FDA UDI
Primary DI / UDI-DI: B017AS100 FDA UDI
FDA Product Code: ITX FDA UDI
IYO FDA UDI
GMDN Term: Ophthalmic ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1560 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

Category: Ophthalmic ultrasound imaging system

ArcScan Insight 100 by Arcscan, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ophthalmic ultrasound imaging system.

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Ellex — ELLEX MEDICAL PTY LTD · Class II
LIGHTSonic B UBM — Light-Med(Usa), Inc. · Class II
Ophthalmic Ultrasound Examination Instrument — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD · Class II
B-scan Plus- VET — ACCUTOME, INC. · Class II
A-scan probe — Nidek, Inc. · Class II

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: Arcscan, Inc.

Sources (1)

FDA UDI 97e889e2-957f-41c0-a97c-9432f925c03f 33 fields · synced May 29, 2026