Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030491946

FEI Number

3030491946

Entity Name

ENVISIONIT DEEP AI Ltd

City/State/Country

Cobham Surrey, GB

Establishment Address

Coveham House, Downside Bridge Road, Cobham, KT11 3 EP, United Kingdom, Cobham Surrey KT11 3 EP, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Envisionit Deep AI (Owner Number: 10090083)

Owner / Operator Contact Address

Coveham House, Downside Bridge Road, Cobham, KT11 3 EP, United Kingdom, Cobham, GB-SRY KT11 3 EP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231871

PMA Number

N/A

All Registered Proprietary Names

Pulmira

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2024-02-13

Official Correspondent

Bhavta Nundkoomar

US Agent Details

Robert Packard Business: Medical Device Academy Incorporated Email: rob@fdaestar.com Phone: (802) 2581881

Related Public Records

Same Entity

Envisionit Deep AI

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190362	Zebra Medical Vision, Ltd.	HealthPNX	2019-05-06

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3017173128	CUREMETRIX, INC.	San Diego, CA, US
3014678441	VIZ.AI, INC.	Cary, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030491946. Last updated year: 2026. Please use registration number 3030491946 when referencing this establishment in official correspondence.