SLT IVUS P1 Display Unit

FDA UDI

Class II (US FDA UDI)

by Provisio Medical, Inc.

Identity

Trade Name: SLT IVUS P1 Display Unit FDA UDI
Generic Name: Cardiovascular ultrasound imaging system FDA UDI
Device Name: See LBL-0998, SLT IVUS P1 System Manual FDA UDI
Model / Reference: DU0001 FDA UDI
Description: See LBL-0998, SLT IVUS P1 System Manual FDA UDI

Identifiers

Catalog Number: DU0001 FDA UDI
Primary DI / UDI-DI: 00850045446031 FDA UDI
510(k) Number: K233948 FDA UDI
FDA Product Code: OBJ FDA UDI
DQY FDA UDI
ITX FDA UDI
IYO FDA UDI
GMDN Term: Cardiovascular ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1200 FDA UDI
870.1250 FDA UDI
892.1570 FDA UDI
892.1560 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Cardiovascular ultrasound imaging system

SLT IVUS P1 Display Unit by Provisio Medical, Inc. — 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
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
Medistim MiraQ Vascular System — Medi-Stim Asa · Class II

Cleared under the same submission

K233948 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Provisio Medical, Inc.

Sources (1)

FDA UDI 6763dc11-33ce-476c-b6ee-3de1992f40d8 36 fields · synced May 30, 2026