Duns Number:078766464
Device Description: The handheld transducer is a 2 MHz single-element ultrasound transducer designed to be hel The handheld transducer is a 2 MHz single-element ultrasound transducer designed to be held by hand to perform velocity measurements.The transducer has the following specifications:• 2MHz ± 0.1MHz center frequency• 46mm ± 5mm focal length• 16mm active diameter• Fractional 6dB pulse-echo bandwidth = 60% to 80%• Round-trip insertion loss < 6dB• Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase
Catalog Number
NA – PRB1
Brand Name
2-MHz Transducer, Handheld
Version/Model Number
40-00008
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
K160442
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
24893d71-2cfb-403f-b38f-914239bc7558
Public Version Date
August 19, 2022
Public Version Number
5
DI Record Publish Date
May 25, 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. | 18 |