FDA.reportPublic FDA data

Invenia

Primary DI
00195278756138
Brand
Invenia
Company
GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC
Model
ABUS R2.5 Prime
Catalog number
H5023S2-H5013S2
Device description
Invenia ABUS Prime
Published
2025-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
PAAAutomated Breast Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAAAutomated Breast UltrasoundUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P110006011

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110006011SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)GE Healthcare2012-09-18PAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278756138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278756138001952787561381952787561380195278756138

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Special Storage Condition, Specify00Operating condition Altitude: 0 to 3000 meters
Special Storage Condition, Specify00Storing condition Altitude: 0 to 5000 meters
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119309548
Device count
1
Serial number
true
Manufacturing date on label
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
00195278756237InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2025-03-04
10197106527344CARDINAL HEALTHCardinal Health 200, LLCPAA2024-02-02
50197106527342CARDINAL HEALTHCardinal Health 200, LLCPAA2024-02-02
10197106530061CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-21
50197106530069CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-21
10197106493168CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-14
50197106493166CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-14
10197106471609CARDINAL HEALTHCardinal Health 200, LLCPAA2023-10-05
50197106471607CARDINAL HEALTHCardinal Health 200, LLCPAA2023-10-05
10197106038543CARDINAL HEALTHCardinal Health 200, LLCPAA2023-06-05
50197106038541CARDINAL HEALTHCardinal Health 200, LLCPAA2023-06-05
10197106192573CARDINAL HEALTHCardinal Health 200, LLCPAA2023-03-30
50197106192571CARDINAL HEALTHCardinal Health 200, LLCPAA2023-03-30
00860000221306SoftVueDelphinus Medical Technologies, IncPAA2022-12-07
10195594787271CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-12
50195594787279CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-12
10195594783907CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-10
50195594783905CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-10
00840682141161InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2018-09-04
10885425282814CARDINAL HEALTHCARDINAL HEALTH 200, LLCPAA2016-07-27
50885425282812CARDINAL HEALTHCardinal Health 200, LLCPAA2016-07-27
00840682100090InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2016-01-29
00840682100014InveniaGE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLCPAA2014-09-24
00840682100021InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2014-09-24
00840682100038InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2014-09-24