DEVICE: PHASED ARRAY TRANSDUCER (04987670004377)

Device Identifier (DI) Information

PHASED ARRAY TRANSDUCER
PSU-70BT
In Commercial Distribution

CANON MEDICAL SYSTEMS CORPORATION
04987670004377
GS1

1
690575113 *Terms of Use
PHASED ARRAY TRANSDUCER
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Surgical ultrasound imaging transducer A hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications. It is sometimes referred to as a surgical probe or fingertip probe. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. This group of devices includes ultrasound imaging transducer assemblies used with A-mode, B-mode, M-mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ITX Transducer, ultrasonic, diagnostic
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K143027 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Hydrogen Peroxide
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

bbe9e561-4196-4af2-b2a3-1b140392347c
July 06, 2018
4
September 01, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1-8004211968
xxx@xxx.xxx
CLOSE