Chest-CAD

Primary DI
00852491008023
Brand
Chest-CAD
Company
Imagen Technologies, Inc.
Model
1.0.0
Device description
Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD uses machine learning techniques to identify, highlight, and categorize suspicious regions of interest (ROI) in adult chest X-rays. Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. 00852491008016
Published
2021-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MYNAnalyzer, Medical Image

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYNAnalyzer, Medical ImageRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210666000Chest-CADImagen Technologies, Inc.2021-07-20MYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852491008023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852491008023008524910080238524910080230852491008023

GMDN Terms#

Term, Definition table
TermDefinition
X-ray image interpretive softwareAn interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042356781
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852491008047ChestSuite1.0.02026-04-15
00852491008030Aorta-CAD1.0.02023-04-06
00852491008016FractureDetect (FX)1.0.02021-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262352357935DS Core DetectZetta25 AGMYN2026-06-03
00852491008047ChestSuiteImagen Technologies, Inc.MYN2026-04-15
00860015071101SugarBotBENCH7 INC.MYN2026-04-08
07332747236620DTX Studio™ ClinicNobel Biocare ABMYN2026-03-27
07332747236637DTX Studio™ ClinicNobel Biocare ABMYN2026-03-27
08801643467098NASamsung Electronics Co., Ltd.MYN2026-03-17
00860010268063DiagnocatDGNCT LLCMYN2026-01-29
07332747221855DTX Studio™ AssistNobel Biocare ABMYN2025-12-01
07332747221862DTX Studio™ AssistNobel Biocare ABMYN2025-12-01
07332747225501DTX Studio™ ClinicNobel Biocare ABMYN2025-10-06
07332747225518DTX Studio™ ClinicNobel Biocare ABMYN2025-10-06
00198715016079Second OpinionPearl Inc.MYN2025-07-31
M722X25122C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-06-17
M722XC25114C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-06-17
M722XD25114C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-06-17
07332747221183DTX Studio™ ClinicNobel Biocare ABMYN2025-04-24
07332747221190DTX Studio™ ClinicNobel Biocare ABMYN2025-04-24
08908023670038DeepTek CXR AnalyzerDEEPTEK MEDICAL IMAGING PRIVATE LIMITEDMYN2025-04-24
03770020839092ChestView USGLEAMERMYN2025-04-02
M722X25064C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-03-27
M722XC25064C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-03-27
M722XD25064C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-03-27
07332747219616DTX Studio™ ClinicNobel Biocare ABMYN2025-01-26
07332747219623DTX Studio™ ClinicNobel Biocare ABMYN2025-01-26
00860003567920Second OpinionPearl Inc.MYN2025-01-10
00860010893203Velmeni for DentistsVelmeni Inc.MYN2024-12-11
00860005586318Overjet Caries AssistOverjet, Inc.MYN2024-11-12
00860005586325Overjet Calculus AssistOverjet, Inc.MYN2024-11-12
00860005586332Overjet Periapical Radiolucency AssistOverjet, Inc.MYN2024-11-12
00860005586363Overjet Caries Assist-PediatricOverjet, Inc.MYN2024-11-12