PacScan Plus

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 300AP+Model 300 AP+

by Sonomed, Inc.

Identity

Trade Name: PacScan Plus EUDAMED
PacScan 300 Plus Ophthalmic Ultrasound FDA UDI
Generic Name: Ophthalmic ultrasound imaging system FDA UDI
Device Name: PacScan Ophthalmic Ultrasound EUDAMED
The PacScan 300 Plus ophthalmic ultrasound system is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The system integrates A-Scan and Pachymeter capabilities into a single system. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The pachymeter is a biometric device that allows for measuring and mapping corneal thickness. The 300A+ A-Scan model can be used to collect scan data using the direct contact or immersion method. There are five examination modes: Cataract, Dense Cataract, Aphakic, Pseudophakic and 4-Gate Manual. The pachymeter uses a higher frequency signal to measure shorter distances. The PacScan 300AP+ system includes a 6" color LCD, touch screen, built-in thermal printer, 10 MHz A-probe, 20 MHz Pachymeter probe, foot switch and operator manual. FDA UDI
Model / Reference: 300 AP+ EUDAMED
300AP+ EUDAMED
300AP+ A-Scan/Pachymeter FDA UDI
Description: The PacScan 300 Plus ophthalmic ultrasound system is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The system integrates A-Scan and Pachymeter capabilities into a single system. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The pachymeter is a biometric device that allows for measuring and mapping corneal thickness. The 300A+ A-Scan model can be used to collect scan data using the direct contact or immersion method. There are five examination modes: Cataract, Dense Cataract, Aphakic, Pseudophakic and 4-Gate Manual. The pachymeter uses a higher frequency signal to measure shorter distances. The PacScan 300AP+ system includes a 6" color LCD, touch screen, built-in thermal printer, 10 MHz A-probe, 20 MHz Pachymeter probe, foot switch and operator manual. FDA UDI

Identifiers

Catalog Number: 300AP+ FDA UDI
Primary DI / UDI-DI: 00896100002095 EUDAMEDFDA UDI
Basic UDI-DI: B-00896100002095 EUDAMED
510(k) Number: K092637 FDA UDI
FDA Product Code: ITX FDA UDI
EMDN Code: Z11040199 ULTRASOUND SCANNERS - OTHER EUDAMED
GMDN Term: Ophthalmic ultrasound imaging system FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
Market of Registration: Spain EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

PacScan Plus by Sonomed, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-00896100002095	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Sonomed, Inc.
EUDAMED SRN: US-MF-000002342
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (2)

EUDAMED 71d3f148-7dc1-4da1-94cf-067c04f86cf9 61 fields · synced May 31, 2026
FDA UDI d12d7bf6-ab09-4cae-9a90-a62c27cf1831 36 fields · synced May 29, 2026