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FDA 510(k)

P-Cure Proton Beam Therapy System

K-Number: K221996 · 2023-03-20

ApplicantP-Cure, Ltd.
Decision Date2023-03-20
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

P-Cure Proton Beam Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is P-Cure, Ltd.. It received FDA 510(k) clearance on 2023-03-20 under 510(k) number K221996. 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 P-Cure Proton Beam Therapy System?

P-Cure Proton Beam Therapy System is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is P-Cure, Ltd.. The 510(k) number is K221996.

When did P-Cure Proton Beam Therapy System receive FDA 510(k) clearance?

P-Cure Proton Beam Therapy System received FDA 510(k) clearance on 2023-03-20, under 510(k) number K221996.

Who is the listed applicant for P-Cure Proton Beam Therapy System?

The FDA 510(k) record lists P-Cure, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P-Cure Proton Beam Therapy System?

The FDA product code for P-Cure Proton Beam Therapy System is LHN.

Other records listing P-Cure, Ltd. as applicant

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.

K242418P-Cure Proton Therapy System (PPTS)K160611P-ARTIS

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

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

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