neuroinspire

FDA UDI

Class II (US FDA UDI)

by Renishaw P L C

Identity

Trade Name: neuroinspire FDA UDI
Generic Name: Image segmentation application software FDA UDI
Device Name: neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures. FDA UDI
Model / Reference: A-5630-3008 FDA UDI
Description: neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures. FDA UDI

Identifiers

Primary DI / UDI-DI: 05057078000024 FDA UDI
510(k) Number: K163666 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Image segmentation application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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

Category: Image segmentation application software

neuroinspire by Renishaw P L C — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Renishaw P L C

Sources (1)

FDA UDI a355a502-2289-4acb-af1a-1b5f3063ae4a 34 fields · synced Jun 8, 2026