Duns Number:738574953
Device Description: AVISO (S) Ophthalmic A (A-Std), B Scan and UBM Ultrasound SystemThe QUANTEL MEDICAL AVISO AVISO (S) Ophthalmic A (A-Std), B Scan and UBM Ultrasound SystemThe QUANTEL MEDICAL AVISO modular platform is an ultrasound system intended to be 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(• 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.)
Catalog Number
-
Brand Name
AVISO (S)
Version/Model Number
AVISO (S)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051851
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
97c42063-fcba-41d5-b4d9-16fde32a2ff8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |