Caption

Primary DI
00198953038604
Brand
Caption
Company
GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC
Model
Guidance
Device description
Caption Cardiac Guidance on Venue
Published
2025-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
QJUImage Acquisition And/Or Optimization Guided By Artificial Intelligence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJUImage Acquisition And/Or Optimization Guided By Artificial IntelligenceRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN190040000
K243065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190040000Caption GuidanceBay Labs, Inc.2020-02-07QJU
K243065000Cardiac GuidanceCaption Health, Inc.2025-01-15QJU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953038604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953038604001989530386041989530386040198953038604

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
119309548
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953100509Automated Aortic StenosisA-1.02026-05-05
00195278516480VenueR42022-06-30
00195278516497Venue FitR42022-06-30
00195278516510Venue GoR42022-06-27
00195278384041LOGIQE10 R32021-11-15
00195278194275Venue FitR32021-01-11
00195278005830VenueR3 UPG2020-11-24
00195278005861Venue GOR3 UPG2020-11-24
00840682190503Venue GoR32020-11-24
00840682100038InveniaABUS WorkstationH5014WS2014-09-24
00840682123815VenueR12017-07-14
00840682138260LOGIQE102018-02-27
00840682138840Venue GoR22019-02-25
00840682138888VenueR22018-06-08
00840682139212VenueR2 UPG2018-06-08
00840682141161InveniaABUS 2.02018-09-04
00840682100090InveniaABUS Review Software2016-01-29
00195278439352LOGIQE10 R1 to R3 UPG2025-12-05
00195278439369LOGIQE10 R2 to R3 UPG2025-12-05
00840682147118LOGIQE10 R1 to R2 UPG2020-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019208075UltraSight GuidanceULTRASIGHT LTDQJU2026-05-25
07290019208068UltraSight GuidanceULTRASIGHT LTDQJU2026-04-20
00198953030233CaptionGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCQJU2025-07-28
00860003586341Caption AI (Caption Guidance + Caption Interpretation)CAPTION HEALTH, INC.QJU2024-04-01
00860003586334Caption GuidanceCAPTION HEALTH, INC.QJU2023-09-30
00860003586310Caption AI (Caption Guidance + Caption Interpretation)CAPTION HEALTH, INC.QJU2022-03-15
00860003586303Caption AI (Caption Guidance + Caption Interpretation)CAPTION HEALTH, INC.QJU2020-06-05