Duns Number:738574953
Device Description: The AXIALIS Ophthalmic Ultrasound System and the probes that are used with it are indicate The AXIALIS Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:• Axial Length measurement of the eye by ultrasonic means.• Implanted IOL power calculation, using the Axial Length measurement.• Measurement of corneal thickness by ultrasonic means.
Catalog Number
-
Brand Name
AXIALIS
Version/Model Number
AXIALIS
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
K213254
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
4d533ed5-b9dc-461b-9081-1aa380127d60
Public Version Date
January 13, 2022
Public Version Number
1
DI Record Publish Date
January 05, 2022
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 |