Model: 3.0
DI: 00858991006194
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9a4e478b-f284-411d-8bd9-35d4be2a5d8b
Distribution Status:
In Commercial Distribution
DUNS Number:
342623907
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00858991006194
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47069
Name: Proton therapy system
Definition:
An 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.
FDA Product Codes
LHN
System, radiation therapy, charged-particle, medical
Premarket Submissions
Submission Number:
K252815
Supplement Number:
000