Duns Number:057188807
Device Description: The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophth The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The system consists of three main components: an interface module with integrated probe holder, one or more ultrasonic probes, and the Scanmate software application.
Catalog Number
-
Brand Name
Scanmate Flex USB Interface
Version/Model Number
Scanmate Flex
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171301
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
facdf668-827c-44f8-a1f3-fddb8b0069d5
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 05, 2017
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. | 21 |