FDA.reportPublic FDA data

B-Right Screen Fetal Heart

Primary DI
03760415600000
Brand
B-Right Screen Fetal Heart
Company
BRIGHTHEART
Model
V1.0.0
Device description
Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.
Published
2025-01-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For CancerRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242342000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242342000Fetal EchoScanBrightheart2024-11-14POK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760415600000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760415600000037604156000003760415600000

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
279036039
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760415600031B-Right Views Fetal HeartV1.x2025-10-13
03760415600048B-Right Screen Fetal HeartV1.1.x2025-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B720BX360EASPECTS1430e-ASPECTSBRAINOMIX LIMITEDPOK2026-05-06
00198953100509Automated Aortic StenosisGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPOK2026-05-05
B720BX360EASPECTS1210Brainomix e-ASPECTSBRAINOMIX LIMITEDPOK2026-03-30
00850012642114Unfold AIAvenda Health, Inc.POK2026-03-06
G762AISAPCARDIOV10AISAP Cardio V1.0AISAP LTDPOK2026-02-18
B720BX360EASPECTS1420e-ASPECTSBRAINOMIX LIMITEDPOK2026-02-03
00850012642107Unfold AIAvenda Health, Inc.POK2025-11-24
B720BX360EASPECTS1200e-ASPECTSBRAINOMIX LIMITEDPOK2025-10-15
B720BX360EASPECTS1410e-ASPECTSBRAINOMIX LIMITEDPOK2025-10-13
03760415600048B-Right Screen Fetal HeartBRIGHTHEARTPOK2025-10-13
00850012642091Unfold AIAvenda Health, Inc.POK2025-09-29
03770024341034Sonio SuspectSONIOPOK2025-09-03
B720BX360EASPECTS1400e-ASPECTSBRAINOMIX LIMITEDPOK2025-08-18
B761R60Rapid Ischemaview, Inc.POK2025-05-07
B720BX360EASPECTS113e-ASPECTSBRAINOMIX LIMITEDPOK2025-04-15
00850012642084Unfold AIAvenda Health, Inc.POK2025-03-31
00850012642077Unfold AIAvenda Health, Inc.POK2025-03-17
00850012642060Unfold AIAvenda Health, Inc.POK2025-02-12
00882916001025StrokeSENS LVOCircle Cardiovascular Imaging IncPOK2025-02-05
00850012642053Unfold AIAvenda Health, Inc.POK2024-11-20
09309001128005EchoSolv ASECHOIQ LIMITEDPOK2024-11-14
00850012642046Unfold AIAvenda Health, Inc.POK2024-09-18
00850012642039Unfold AIAvenda Health, Inc.POK2024-05-07
B826CINAASPECTS150CINA-ASPECTSAVICENNA.AIPOK2024-03-29
B761R5711RapidIschemaview, Inc.POK2024-02-13
B761R5721RapidIschemaview, Inc.POK2024-02-13
B761R610RapidIschemaview, Inc.POK2024-02-13
00850012642022Unfold AIAvenda Health, Inc.POK2023-12-18
B761R5701RapidIschemaview, Inc.POK2023-06-29
B761R591RapidIschemaview, Inc.POK2023-06-29