ScreenPoint Medical, Inc.

FDA Device Registration & Listing · Dover, DE, US · Registration 3030412475

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
3030412475
FEI Number
3030412475
Entity Name
ScreenPoint Medical, Inc.
City/State/Country
Dover, DE, US
Establishment Address
8 The Green, Suite B, Dover, DE 19901, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
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
Y
Expiration Date (Year)
2026
510(k) Number
K221347
PMA Number
N/A

All Registered Proprietary Names

Transpara SR Converter Transpara 1.7.y Transpara Transpara Transpara 1.7.2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer Radiology Class 2 892.2090 2020-03-06
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 2022-08-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3015173173 SCREENPOINT MEDICAL Nijmegen Gelderland, NL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030412475. Last updated year: 2026. Please use registration number 3030412475 when referencing this establishment in official correspondence.
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