FDA.reportPublic FDA data

EPIQ 7W Ultrasound System

Primary DI
00884838107489
Brand
EPIQ 7W Ultrasound System
Company
Philips Ultrasound LLC
Model
795202
Published
2021-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
LLZSystem, Image Processing, Radiological
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
LLZSystem, Image Processing, RadiologicalRadiology2
OBJCatheter, Ultrasound, IntravascularCardiovascular2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211597000EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems2021-09-08IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838107489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838107489008848381074898848381074890884838107489

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
Serial number
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
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00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24