PRONOVA SC360 (UDI R1.0)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The PRONOVA SC360 (Model/Catalog Number: R1.0) is a medical device manufactured by PRONOVA SOLUTIONS, LLC. This product is indexed under FDA Product Code / Category Classification LHN within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: R1.0
Product Code / EMDN: LHN
Device Name: Proton Therapy System
Database Sync Date: 2026-08-09 09:49:15

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of PRONOVA SC360?

The registered manufacturer of record for PRONOVA SC360 is PRONOVA SOLUTIONS, LLC.

What is the Primary UDI-DI identifier for PRONOVA SC360?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is R1.0.

What classification code is assigned to this device?

This device is registered under product classification code LHN.

Similar Classification Devices (LHN)

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