Scanmate Flex USB Interface

GUDID 00857377006117

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.

DGH TECHNOLOGY INC.

Ophthalmic ultrasound imaging transducer

• Primary Device ID: 00857377006117
• NIH Device Record Key: facdf668-827c-44f8-a1f3-fddb8b0069d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scanmate Flex USB Interface
• Version Model Number: Scanmate Flex
• Company DUNS: 057188807
• Company Name: DGH TECHNOLOGY INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857377006117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171301

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-05

Devices Manufactured by DGH TECHNOLOGY INC.

• 00857377006001 - Pachmate 2: 2018-07-06 The DGH 55B is a Handheld Ultrasonic Pachymeter. It is a hand-held, battery-powered electronic medical device that uses ultrason
• 00857377006018 - Pachette 4: 2018-07-06 The DGH 555B is a Desktop Ultrasonic Pachymeter. It is a portable, battery-powered electronic medical device that uses ultrasoni
• 00857377006094 - Scanmate A: 2018-07-06 The DGH 6000 is a Portable Ultrasonic A-Scan. It is an electronic device that connects to the user's PC via USB connection. It i
• 00857377006100 - Scanmate B: 2018-07-06 The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The
• 00857377006117 - Scanmate Flex USB Interface: 2018-07-06The 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.
• 00857377006117 - Scanmate Flex USB Interface: 2018-07-06 The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophthalmic application, intended to both vi
• 00857377006124 - 20 MHz B-Scan Probe: 2018-07-06 The DGH1920 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, w
• 00857377006131 - 12.5 MHz B-Scan Probe: 2018-07-06 The DGH1912 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, w
• 00857377006148 - UBM Probe: 2018-07-06 The DGH1500 is a single-element mechanical sector UBM probe. This probe connects to the Scanmate Flex USB interface module, whic