FDA UDI In Commercial Distribution 🇺🇸 United States

TechLive

DI: 00860005144044 · Model: 1.2.1 · Deephealth, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TechLive
Primary DI
00860005144044
Version / Model
1.2.1
Company Name
Deephealth, Inc.
Labeler DUNS
081336616
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-04-22
Public Version
1
Public Version Date
2026-04-30
Public Version Status
New
Public Device Record Key
822f1c1f-b5a7-429e-93ac-3fbbec1f5a70

Device Description

TechLive is a software application intended to provide remote access for real-time image acquisition, assistance, review, monitoring and standardization of imaging devices across multiple locations. It is a vendor neutral solution allowing read-only or full access control to connected devices. TechLive is also intended for training of medical personnel working on medical imaging devices. TechLive is not intended for diagnostic use. Clinical users can remotely access imaging devices from a computer via a secure software connection that streams video and audio, including access to keyboard and mouse controls. This setup allows remote users to assist local in-suite assistants or other clinical users by means of audio/video connection or perform remote acquisitions themselves. Depending upon the device used to acquire the images, the remote access can allow for "view mode", to support the in-suite assistant, or "control mode", where the remote user controls the console software of the imaging device. Remote access to the local imaging device can only be granted by the local in-suite assistant and can be granted or revoked as needed using an on-premises computer installed with the assistance touch interface. “Control mode” access may be granted on-demand or prior to acquisition to access the scanner. TechLive offers a secure collaboration platform with live audio and video, enabling remote acquisition and seamless collaboration among healthcare professionals. TechLive is vendor-neutral and compatible with existing imaging devices, including Ultrasound (US), Magnetic Resonance Imaging (MRI), Computer Tomography (CT), and Positron Emission Tomography (PET/CT).

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LLZ System, Image Processing, Radiological

GMDN Terms

Code Name
60724 Multidisciplinary medical image management software

Identifiers

Type ID
Primary 00860005144044

Premarket Submissions

Submission Number Supplement Number
K243703 000