PRONOVA SC360

Primary DI
00863274000301
Brand
PRONOVA SC360
Company
PRONOVA SOLUTIONS, LLC
Model
R1.0
Device description
Proton Therapy System
Published
2018-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162246000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162246000ProNova SC360 Proton Therapy SystemPronova Solutions, LLC2016-12-08LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863274000301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863274000301008632740003018632740003010863274000301

GMDN Terms#

Term, Definition table
TermDefinition
Proton therapy systemAn assembly of devices/sub-systems designed to produce and deliver a transverse- and longitudinal-dose proton beam to treat localized tumours and other conditions susceptible to treatment by radiation. It typically consists of components for beam production, transport and delivery; patient positioning; system and component control; and software. It will typically be configured to a particular site’s requirements.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968714563
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863274000318ProNova SC360R1.12018-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850065937250eMotusEMPNIA INC.LHN2026-09-21
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