EnVisio

FDA UDI

Class II (US FDA UDI)

by Elucent Medical Inc.

Identity

Trade Name: EnVisio FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: EnVisio Navigation System: contains EnVisio Navigation Patient Pad and EnVisio Navigation System Heads Up Display FDA UDI
Model / Reference: ENVISIO-SYS FDA UDI
Description: EnVisio Navigation System: contains EnVisio Navigation Patient Pad and EnVisio Navigation System Heads Up Display FDA UDI

Identifiers

Catalog Number: ENVISIO-SYS FDA UDI
Primary DI / UDI-DI: 00851674008034 FDA UDI
510(k) Number: K183400 FDA UDI
FDA Product Code: NEU FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Radiological image marker, implantable

EnVisio by Elucent Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K183400 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: Elucent Medical Inc.

Sources (1)

FDA UDI 0ec4e1ae-9744-44f2-9714-93ba8d47d400 36 fields · synced Jun 8, 2026