Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015173173

FEI Number

3015173173

Entity Name

SCREENPOINT MEDICAL

City/State/Country

Nijmegen Gelderland, NL

Establishment Address

Mercator II, 7th floor, Toernooiveld 300, Nijmegen Gelderland 6525 EC, NL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

ScreenPoint Medical (Owner Number: 10059521)

Owner / Operator Contact Address

Mercator II, 7th floor, Toernooiveld 300, Nijmegen, NL-GE 6525 EC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210404

PMA Number

N/A

All Registered Proprietary Names

Transpara Transpara Transpara Transpara Transpara SR Converter Transpara 1.7.y

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2024-11-26
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2020-03-06
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-12-18
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2019-12-11
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2020-10-02
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2021-06-23

Official Correspondent

No official correspondent registered.

US Agent Details

Shilpa Gampa Business: FREYR INC Email: usagent@freyrsolutions.com Phone: (760) 5834401

Related Public Records

Same Entity

ScreenPoint Medical

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3030412475	ScreenPoint Medical, Inc.	Dover, DE, US

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015173173. Last updated year: 2026. Please use registration number 3015173173 when referencing this establishment in official correspondence.