Scanmate B

GUDID 00857377006100

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 DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye.

DGH TECHNOLOGY INC.

Ophthalmic ultrasound imaging transducer

• Primary Device ID: 00857377006100
• NIH Device Record Key: eda29865-80a8-49a5-abcc-63eb1e081d1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scanmate B
• Version Model Number: DGH 8000
• 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	00857377006100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070907

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: 2016-10-11

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: 2018-07-06The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye.
• 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: 2018-07-06 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