ABSOLU

Basic Information

• Brand Name: ABSOLU
• Primary DI: 03700542625521
• Version / Model: ABSOLU
• Company Name: QUANTEL MEDICAL
• Labeler DUNS: 738574953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-09
• Public Version: 1
• Public Version Date: 2019-07-17
• Public Version Status: New
• Public Device Record Key: 2b4fefce-afdb-47cb-afe7-0edb42523ec0

Device Description

The ABSolu is a high definition multifunction ophthalmic ultrasound system used for: - Axial Length measurement of the eye by ultrasonic means; - Implanted IOL power calculation, using the axial length measurement; - Visualization of the interior of the eye and the orbit by A and B scans. - ABSOLU S only: Advanced diagnostic - Standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11389	Ophthalmic ultrasound imaging system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700542625521	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K183414	000