FDA.reportPublic FDA data

Automated Aortic Stenosis

Primary DI
00198953100509
Brand
Automated Aortic Stenosis
Company
GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC
Model
A-1.0
Device description
Automated Aortic Stenosis
Published
2026-05-05
Public version status
Update
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
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
K254161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254161000Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2026-03-27POK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953100509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953100509001989531005091989531005090198953100509

GMDN Terms#

Term, Definition table
TermDefinition
Echocardiographic softwareA software program intended to display and analyse/process ultrasound images of the heart, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of a cardiac condition (e.g., heart failure, amyloidosis). It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
119309548
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00198953183984LunarAstra2026-10-19
00198953042748LOGIQE10 R4_R5 UPG2025-12-05
00198953042816LOGIQE10 R55935000E10-52025-12-05
00198953001400VenueR6 UPG2025-11-17
00195278756138InveniaABUS R2.5 PrimeH5023S2-H5013S22025-03-12
00195278756237InveniaABUS R2.5 PremiumH5023S1-H5013S12025-03-04
00195278439352LOGIQE10 R1 to R3 UPG2025-12-05
00195278439369LOGIQE10 R2 to R3 UPG2025-12-05
00195278384041LOGIQE10 R32021-11-15
00195278005830VenueR3 UPG2020-11-24
00195278005861Venue GOR3 UPG2020-11-24
00840682145640LOGIQE10 R22020-05-04
00840682138260LOGIQE102018-02-27
00195278516480VenueR42022-06-30
00195278516497Venue FitR42022-06-30
00195278516510Venue GoR42022-06-27
00195278194275Venue FitR32021-01-11
00840682190503Venue GoR32020-11-24
00840682100038InveniaABUS WorkstationH5014WS2014-09-24
00840682123815VenueR12017-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850012642121Unfold AIAvenda Health, Inc.POK2026-08-19
00860012425303RevealAI-LungPrecision Medical Ventures Inc.POK2026-05-29
B720BX360EASPECTS1430e-ASPECTSBRAINOMIX LIMITEDPOK2026-05-06
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
B761R60RapidIschemaview, 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
03760415600000B-Right Screen Fetal HeartBRIGHTHEARTPOK2025-01-28
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