Device
INTDose is FDA-cleared (K213137) software intended to support the delivery of therapeutic radiation by performing independent dose calculation and verification for radiation therap...
Manufacturer
Carina Medical LLC
Carina Medical LLC
Model: 1.6.3
DI: 00860015780812
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
INTDose is FDA-cleared (K213137) software intended to support the delivery of therapeutic radiation by performing independent dose calculation and verification for radiation therapy treatment plans. INTDose is intended for use by qualified medical professionals; all output requires clinician review and approval before clinical use.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ae0ed61f-8f1b-4a97-92d4-675ae845375d
Distribution Status:
In Commercial Distribution
DUNS Number:
081070086
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860015780812
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40887
Name: Radiation therapy software
Definition:
An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.
FDA Product Codes
IYE
Accelerator, Linear, Medical
Premarket Submissions
Submission Number:
K213137
Supplement Number:
000