FDA.reportPublic FDA data

See-Mode Technologies

Primary DI
00860006305734
Brand
See-Mode Technologies
Company
SEE-MODE TECHNOLOGIES PTE. LTD.
Model
See-Mode Augmented Reporting Tool, Breast (SMART-B
Device description
Localization and characterization of breast ultrasound images.
Published
2026-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260303000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260303000See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.2026-07-28QDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006305734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006305734008600063057348600063057340860006305734

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Regulatory Flags#

DUNS number
659470225
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860006305727See-Mode TechnologiesSee-Mode Augmented Reporting Tool, Thyroid (SMART-2024-11-22
00860006305703See-Mode TechnologiesAVA (Augmented Vascular Analysis)2023-08-16

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Primary DI, Brand, Company table
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08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.QIH2026-05-06
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08800124700136SwiftMRAIRS Medical Inc.QIH2026-04-01
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B720BX360ECTA1210Brainomix 360 e-CTABRAINOMIX LIMITEDQIH2026-03-30
08800066200626MEDIHUB PROSTATEJLK, Inc.QIH2026-03-25
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08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.QIH2026-02-24
G762AISAPCARDIOV10AISAP Cardio V1.0AISAP LTDQIH2026-02-18
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08800290027471EV2-12SAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.QIH2026-01-28