ASTRA
CANDELIS, INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005919188 | 3005919188 | CANDELIS, INC. | 1 | N | 2026-01-01 | 9903 South Santa Monica Blvd, #2101 Beverly Hills CA US 90212 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B193IG10B0 | IMAGEGRID RADIOLOGY VIEWER SYSTEM - ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. | 18888008600 | support@candelis.com |
| B193IG10BDR0 | IMAGEGRID RADIOLOGY VIEWER SYSTEM - ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. | 18888008600 | support@candelis.com |
| B193IG10H0 | IMAGEGRID RADIOLOGY VIEWER SYSTEM - ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. | 18888008600 | support@candelis.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 67246 | 1374892820 | K111694 | ASTRA | LLZ | 2011-09-15 |
| 67246 | 1140915292 | K092949 | IMAGEGRID RADIOLOGY VIEWER SYSTEM | LLZ | 2009-10-08 |
| 67246 | 2039747655 | K080333 | IMAGEGRID | LLZ | 2008-02-22 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LLZ | 3 | 2011-09-15 |
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