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VIDA Insights

FDA UDI

Class II (US FDA UDI)

by Vida Diagnostics

Identity

Trade Name
VIDA Insights FDA UDI
Generic Name
CT system application software FDA UDI
Device Name
VIDA Insights is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images. FDA UDI
Model / Reference
3.x FDA UDI
Description
VIDA Insights is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images. FDA UDI

Identifiers

Primary DI / UDI-DI
00852426007022 FDA UDI
510(k) Number
K200990 FDA UDI
FDA Product Code
JAK FDA UDI
GMDN Term
CT system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: CT system application software

VIDA Insights by Vida Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CT system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vida Diagnostics

Sources (1)

  • FDA UDI 7ee2bc2a-0de0-4cdd-81eb-35bc02197542 35 fields · synced May 30, 2026