FDA.reportPublic FDA data

Affiniti 70 Diagnostic Ultrasound System

Primary DI
00884838114258
Brand
Affiniti 70 Diagnostic Ultrasound System
Company
Philips Ultrasound LLC
Model
795119
Device description
Software Version 10.0.2; Affiniti 70 Diagnostic Ultrasound System Circular Edition
Published
2024-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
OBJCatheter, Ultrasound, Intravascular
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
OBJCatheter, Ultrasound, IntravascularCardiovascular2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838114258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838114258008848381142588848381142580884838114258

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063377717
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838130425Transducer V9-23000162230612026-04-14
00884838130432Transducer MC12-33000162230912026-04-14
00884838130449Transducer ML26-83000162231212026-04-14
00884838112988Affiniti 30 Diagnostic Ultrasound System7951802026-01-08
00884838124929Affiniti 30 Diagnostic Ultrasound System7951802026-01-08
00884838127098Affiniti 50 Diagnostic Ultrasound System7951182026-01-08
00884838127111EPIQ 5 Diagnostic Ultrasound System7951202026-01-08
00884838127128EPIQ Elite Diagnostic Ultrasound System7951252026-01-08
00884838126305EPIQ Diagnostic Ultrasound System7954182025-10-17
00884838126893EPIQ Diagnostic Ultrasound System7951222025-06-23
00884838126930EPIQ Diagnostic Ultrasound System7952322025-06-23
00884838124912EPIQ Elite Diagnostic Ultrasound System7952342024-12-19
00884838124974Affiniti 30 Diagnostic Ultrasound System7952182024-12-19
00884838124981Affiniti 50 Diagnostic Ultrasound System7952082024-12-19
00884838124998Affiniti 70 Diagnostic Ultrasound System7952102024-12-19
00884838125674Affiniti CVx Diagnostic Ultrasound System Circular Edition7954072024-06-12
00884838125643EPIQ CVx Diagnostic Ultrasound System7951222024-06-03
00884838125650EPIQ Series Diagnostic Ultrasound System7951172024-06-03
00884838123960EPIQ Diagnostic Ultrasound System7952312024-05-29
00884838123977EPIQ Diagnostic Ultrasound System7952322024-05-29

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00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24
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00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
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00841517112677L15-4FUJIFILM SONOSITE, INC.IYN2026-06-24
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04068151086584LungMapsSiemens Healthineers AGQIH2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
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00841517112639L12-3FUJIFILM SONOSITE, INC.IYO2026-06-22
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