GUDID 08801643467098

The Auto Lung Nodule Detection is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 10 to 30 mm in size. It is designed to aid the physician to review the PA chest radiographs of adults as a second reader and be used as part of S-Station, which is operation software installed on Samsung Digital X-ray Imaging systems. Auto Lung Nodule Detection cannot be used on the patients who have lung lesions other than abnormal nodules.

Samsung Electronics Co., Ltd.

Diagnostic x-ray digital imaging system workstation application software
Primary Device ID08801643467098
NIH Device Record Key0ba77c10-3c67-4d1f-bc15-8482248afbba
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAuto Lung Nodule Detection
Company DUNS687967554
Company NameSamsung Electronics Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108801643467098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYNAnalyzer, Medical Image

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-25
Device Publish Date2026-03-17

Devices Manufactured by Samsung Electronics Co., Ltd.

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