FDA.reportPublic FDA data

Invenia

Primary DI
00840682100014
Brand
Invenia
Company
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
Model
ABUS System
Catalog number
H5014PM
Published
2014-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
P110006001
P110006002
P110006003

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110006001SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)GE Healthcare2012-09-18PAA
P110006002SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)GE Healthcare2012-09-18PAA
P110006003SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)GE Healthcare2012-09-18PAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682100014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682100014008406821000148406821000140840682100014

GMDN Terms#

Term, Definition table
TermDefinition
Breast ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to give reproducible images of the breast. It typically includes software packages that support a variety of static or real-time breast specific imaging used primarily for oncology. It will generate ultrasound pulses, direct them to a the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic two- or three-dimensional (3-D) images.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage Altitude: 0 to 5,000m
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078863378
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682102377LOGIQE92016-08-01
00840682102407LOGIQE9 R4 to XDclear 2.0 UPG2016-08-01
00840682102414LOGIQE9 R5 to XDclear 2.0 UPG2016-08-01
00840682102421LOGIQE9 R3 to XDclear 2.0 UPG2016-08-01
00840682120159LOGIQE9 R4 to R5 UPG2016-07-01
00840682120173LOGIQE9 R3 to R4 UPG2016-06-29
00840682124324LOGIQ E95205000-82017-03-22
00840682143165NAS4-102018-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278756138InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2025-03-12
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
00840682100021InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2014-09-24
00840682100038InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2014-09-24