Conforma 3000® Proton Beam Treatment System

Primary DI
00884400540669
Brand
Conforma 3000® Proton Beam Treatment System
Company
Optivus Proton Therapy, Inc.
Model
Conforma 3000®
Device description
Integrated proton beam therapy system intended for the delivery of proton radiation therapy for the treatment of patients with localized tumors requiring radiation therapy.
Published
2026-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
K992414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992414000PROTON BEAM THERAPY SYSTEM (PBTS)Optivus Technology, Inc.2000-07-21LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884400540669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884400540669008844005406698844005406690884400540669

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.

Contacts#

Phone, Email table
PhoneEmail
909-799-8300slater@optivus.com

Regulatory Flags#

DUNS number
806455929
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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00850065937304eMotusEMPNIA INC.LHN2026-09-21