Aorta-CAD

Primary DI
00852491008030
Brand
Aorta-CAD
Company
Imagen Technologies, Inc.
Model
1.0.0
Device description
Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions of interest (ROIs). The device uses a deep learning algorithm to identify ROIs and produces boxes around the ROIs. The boxes are labeled with one of the following radiographic findings: Aortic calcification or Dilated aorta.Aorta-CAD is intended for use as a concurrent reading aid for physicians looking for ROIs with radiographic findings suggestive of Aortic Atherosclerosis or Aortic Ectasia. It does not replace the role of the physician or of other diagnostic testing in the standard of care. Aorta-CAD is indicated for adults only.
Published
2023-04-06
Public version status
Update
Distribution status
Not 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
K213353000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213353000Aorta-CADImagen Technologies, Inc.2022-09-20MYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852491008030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852491008030008524910080308524910080300852491008030

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
00852491008023Chest-CAD1.0.02021-07-26
00852491008016FractureDetect (FX)1.0.02021-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852491008047ChestSuiteImagen Technologies, Inc.MYN2026-04-15
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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
B630QVCS346QVCAD SystemQVIEW MEDICALMYN2024-06-26