PURPLE AI INC.

FDA Device Registration & Listing · Seocho-gu, Seoul, KR · Registration 3035495311

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035495311
FEI Number
3035495311
Entity Name
PURPLE AI INC.
City/State/Country
Seocho-gu, Seoul, KR
Establishment Address
Room 107, 111 on the 8th floor of Hongwoo Building,, 373, Gangnam-daero,, Seocho-gu, Seoul 06621, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Purple AI Inc. (Owner Number: 10092460)
Owner / Operator Contact Address
Room 107, 111 on the 8th floor of Hongwoo Building,, 373, Gangnam-daero,, Seocho-gu,, KR-11 06621, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K240353
PMA Number
N/A

All Registered Proprietary Names

Hyper Insight

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QAS Radiological Computer-Assisted Triage And Notification Software Radiology Class 2 892.2080 2025-01-16

Official Correspondent

Byungjun Park

US Agent Details

Hannah Taggart Business: Empirical Technologies Email: htaggart@empiricaltech.com Phone: (719) 4571152

Related Public Records

Same Entity

Purple AI Inc.
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
K220709 Aidoc Medical , Ltd. BriefCase 2022-10-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035495311. Last updated year: 2026. Please use registration number 3035495311 when referencing this establishment in official correspondence.
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