Koios Medical, Inc.

FDA Device Registration & Listing · New York, NY, US · Registration 3010119782

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
3010119782
FEI Number
3010119782
Entity Name
Koios Medical, Inc.
City/State/Country
New York, NY, US
Establishment Address
242 West 38th Street, 14th Floor, New York, NY 10018, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Koios Medical, Inc. (Owner Number: 10054621)
Owner / Operator Contact Address
242 West 38th Street, 14th Floor, New York, NY 10018, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242130
PMA Number
N/A

All Registered Proprietary Names

Koios DS Koios DS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2021-12-29
POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer Radiology Class 2 892.2060 2021-12-29
POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer Radiology Class 2 892.2060 2024-11-27
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-11-27

Official Correspondent

Graham Anderson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Koios Medical, 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
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30
K251769 Precision Medical Ventures, Inc. Dba Revealdx RevealAI-Lung 2026-01-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010119782. Last updated year: 2026. Please use registration number 3010119782 when referencing this establishment in official correspondence.
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