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FDA 510(k)

ProNova SC360 Proton Therapy System

K-Number: K162246 · 2016-12-08

ApplicantPronova Solutions, LLC
Decision Date2016-12-08
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ProNova SC360 Proton Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Pronova Solutions, LLC. It received FDA 510(k) clearance on 2016-12-08 under 510(k) number K162246. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProNova SC360 Proton Therapy System?

ProNova SC360 Proton Therapy System is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Pronova Solutions, LLC. The 510(k) number is K162246.

When did ProNova SC360 Proton Therapy System receive FDA 510(k) clearance?

ProNova SC360 Proton Therapy System received FDA 510(k) clearance on 2016-12-08, under 510(k) number K162246.

Who is the listed applicant for ProNova SC360 Proton Therapy System?

The FDA 510(k) record lists Pronova Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProNova SC360 Proton Therapy System?

The FDA product code for ProNova SC360 Proton Therapy System is LHN.

Related Devices (Code: LHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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