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Epiq Cvx Diagnostic Ultrasound System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 795231

by Philips Ultrasound LLC

Identity

Trade Name
EPIQ Diagnostic Ultrasound System EUDAMED
EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM FDA UDI
Generic Name
General-purpose ultrasound imaging system FDA UDI
Device Name
EPIQ Series Diagnostic Ultrasound System EUDAMED
VM11.0 Update FDA UDI
Model / Reference
795231 EUDAMEDFDA UDI
Description
VM11.0 Update FDA UDI

Identifiers

Primary DI / UDI-DI
00884838097933 EUDAMEDFDA UDI
00884838123960 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM431SR EUDAMED
510(k) Number
K233545 FDA UDI
K233788 FDA UDI
K240850 FDA UDI
FDA Product Code
ITX FDA UDI
IYN FDA UDI
IYO FDA UDI
OBJ FDA UDI
QIH FDA UDI
EMDN Code
Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
GMDN Term
General-purpose ultrasound imaging system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
892.1550 FDA UDI
892.1560 FDA UDI
870.1200 FDA UDI
892.2050 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Epiq Cvx Diagnostic Ultrasound System by Philips Ultrasound LLC — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Ultrasound LLC

Sources (4)

  • FDA UDI 651d993e-ac80-445e-8556-69d50cc40bdd 32 fields · synced Oct 7, 2026
  • FDA UDI 9b056261-4af0-46a6-a8e4-54d060443668 34 fields · synced May 30, 2026
  • EUDAMED ff26127a-7bc2-4e8a-bcea-38295e89446a 61 fields · synced Jun 20, 2026
  • EUDAMED eab9ae5f-3d28-4087-8c23-988081031b53 61 fields · synced Jul 25, 2026