PacScan 300 Plus Ophthalmic Ultrasound - The PacScan 300 Plus ophthalmic ultrasound system - SONOMED, INC.

Duns Number:107037079

Device Description: The PacScan 300 Plus ophthalmic ultrasound system is a non-invasive, active device intende 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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

300AP+

Brand Name

PacScan 300 Plus Ophthalmic Ultrasound

Version/Model Number

300AP+ A-Scan/Pachymeter

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092637

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

d12d7bf6-ab09-4cae-9a90-a62c27cf1831

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONOMED, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 23