Ivus-Pim

FDA UDI

Class II (US FDA UDI)

by Philips Image Guided Therapy Corporation

Identity

Trade Name: IVUS-PIM FDA UDI
Generic Name: Cardiovascular ultrasound imaging system FDA UDI
Device Name: Patient interface module for intravascular ultrasound catheters FDA UDI
Model / Reference: 802143001-ROHS FDA UDI
Description: Patient interface module for intravascular ultrasound catheters FDA UDI

Identifiers

Catalog Number: 802143001-ROHS FDA UDI
Primary DI / UDI-DI: 00845225012762 FDA UDI
510(k) Number: K190078 FDA UDI
FDA Product Code: IYO FDA UDI
DSA FDA UDI
DSK FDA UDI
GMDN Term: Cardiovascular ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
870.2900 FDA UDI
870.1110 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiovascular ultrasound imaging system

Ivus-Pim by Philips Image Guided Therapy Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular ultrasound imaging system.

Vivid — GE Medical Systems (China) Co., Ltd. · Class II
iLab™ — Boston Scientific · Class II
SLT IVUS P1 Display Unit — Provisio Medical, Inc. · Class II
iLab Ultrasound Imaging System — Boston Scientific · Class II
iLab Ultrasound Imaging System — Boston Scientific · Class II
AVVIGO™+ — Boston Scientific · Class II
Medistim System Activation Card — Medi-Stim Asa · Class II
AVVIGO™+ — Boston Scientific · Class II

Cleared under the same submission

K190078 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Philips Image Guided Therapy Corporation

Sources (1)

FDA UDI 58566f44-5c7f-43f4-bf44-04b8511aa58f 37 fields · synced Jun 9, 2026