DEVICE: BriefCase Triage (07290018052297)
Device Identifier (DI) Information
BriefCase Triage
23.y.z
In Commercial Distribution
AIDOC MEDICAL LTD
23.y.z
In Commercial Distribution
AIDOC MEDICAL LTD
BriefCase is a radiological computer aided triage and notification software
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 57812 | Radiology DICOM image processing application software |
A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K190896 | 000 |
| K193298 | 000 |
| K213721 | 000 |
| K213886 | 000 |
| K214043 | 000 |
| K220709 | 000 |
| K221240 | 000 |
| K221314 | 000 |
| K221330 | 000 |
| K222277 | 000 |
| K222329 | 000 |
| K222692 | 000 |
| K230020 | 000 |
| K232751 | 000 |
| K241727 | 000 |
| K242837 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
f67ed8b9-cdd9-4fa7-874d-810e1ff954d4
December 02, 2024
1
November 24, 2024
December 02, 2024
1
November 24, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined