PacScan 300 Plus Ophthalmic Ultrasound

Primary DI
00896100002088
Brand
PacScan 300 Plus Ophthalmic Ultrasound
Company
SONOMED, INC.
Model
300A+ A-Scan Only
Catalog number
300A+
Device description
"The PacScan 300 Plus ophthalmic ultrasound system is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. 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 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 PacScan 300A+ system includes a 6"" color LCD, touch screen, built-in thermal printer, 10 MHz A-probe, foot switch and operator manual."
Published
2016-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092637000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092637000PACSCAN PLUS, MODELS 300P AND 300APSonomed, Inc.2009-09-24ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896100002088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896100002088008961000020888961000020880896100002088

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.

Contacts#

Phone, Email table
PhoneEmail
800-227-1285info@sonomedinc.com

Regulatory Flags#

DUNS number
107037079
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00896100002002AXIS Image Management SystemVer 5Axis2022-03-21
00896100002019VuPad Ophthalmic Ultrasound SystemVuPad APAP.5802020-12-07
00896100002026VuPad Ophthalmic Ultrasound SystemVuPad BPBP.5802020-12-07
00896100002033VuPad Ophthalmic Ultrasound SystemVuPad A/B/PBAP.5802020-12-07
00896100002040VuPad Ophthalmic Ultrasound SystemVuPad UBM/PUP.5802020-12-07
00896100002057VuPad Ophthalmic Ultrasound SystemVuPad B/UBM/PBUP.5802020-12-07
00896100002064VuPad Ophthalmic Ultrasound SystemVuPad A/B/UBM/PBUAP.5802020-12-07
00896100002125VuPad Ophthalmic Ultrasound SystemVuPad BB.5802016-08-10
00896100002132VuPad Ophthalmic Ultrasound SystemVuPad A/BBA.5802016-08-10
00896100002149VuPad Ophthalmic Ultrasound SystemVuPad UBMU.5802016-08-10
00896100002156VuPad Ophthalmic Ultrasound SystemVuPad B/UBMBU.5802016-08-10
00896100002163VuPad Ophthalmic Ultrasound SystemVuPad A/B/UBMBUA.5802016-08-10
00896100002170VuPad Ophthalmic Ultrasound SystemVuPad AA.5802016-08-10
00896100002095PacScan 300 Plus Ophthalmic Ultrasound300AP+ A-Scan/Pachymeter300AP+2016-08-10
00896100002101Master-Vu A-Scan Ophthalmic Ultrasound SystemMV4500MV45002016-08-10
00896100002118Master-Vu B-Scan Ophthalmic Ultrasound SystemMV5600MV56002016-08-10
00896100002187VuMAX HD Ophthalmic Ultrasound SystemVuMAX HD B ScanB.5752016-08-10
00896100002194VuMAX HD Ophthalmic Ultrasound SystemVuMAX-HD UBMU.5752016-08-10
00896100002200VuMAX HD Ophthalmic Ultrasound SystemVuMAX HD A/BBA.5752016-08-10
00896100002217VuMAX HD Ophthalmic Ultrasound SystemVuMAX HD A/B/UBMBUA.5752016-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027419LA2-9SDSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290028638CA2-8ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029390EV2-10ASAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029420CV1-8AESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029512LA3-16ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029604L3-22SAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029611LA3-22AISAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029741EA2-11AVESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029789EA2-11ARESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029826CA4-10MSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.ITX2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08800289979132cV4 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07