PacScan 300 Plus Ophthalmic Ultrasound

Primary DI
00896100002095
Brand
PacScan 300 Plus Ophthalmic Ultrasound
Company
SONOMED, INC.
Model
300AP+ A-Scan/Pachymeter
Catalog number
300AP+
Device 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."
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
00896100002095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896100002095008961000020958961000020950896100002095

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
00896100002088PacScan 300 Plus Ophthalmic Ultrasound300A+ A-Scan Only300A+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

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