carinaai.comINTDose
Carina Medical LLC
CARINA MEDICAL LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3022719374 | 3022719374 | CARINA MEDICAL LLC | 1 | N | 2026-01-01 | 42822 Ravenglass Dr Ashburn VA US 20148 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860015780805 | INTContour - INTContour is FDA-cleared (K212274) AI-based image segmentation software intended to assist in radiation therapy treatment planning. The software performs automatic segmentation of anatomical structures including treatment targets and organs at risk on CT and MRI image series. INTContour is intended for use by qualified medical professionals; all output requires clinician review and approval before clinical use. | +1-434-284-1073 | support@carinaai.com |
| 00860015780812 | INTDose - 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. | +1-434-284-1073 | support@carinaai.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 305840 | 2025052194 | K213137 | INTDose | IYE | 2022-05-13 |
| 305840 | 1328574605 | K212274 | INT Contour | MUJ | 2022-04-08 |
Product Codes Associated With Registrations#
PMN#
INT Contour
Carina Medical LLC
GUDID#
INTContour - INTContour is FDA-cleared (K212274) AI-based image segmentation software intended to assist in radiation therapy treatment planning. The software performs automatic segmentation of anatomical structures including treatment targets and organs at risk on CT and MRI image series. INTContour is intended for use by qualified medical professionals; all output requires clinician review and approval before clinical use.
2026-04-27
INTDose - 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.
2026-04-27