odin-vision.comCADDIE
Odin Medical Limited
ODIN MEDICAL LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3031983124 | 3031983124 | ODIN MEDICAL LIMITED | 1 | N | 2027-01-01 | 74 Rivington Street London London, City of GB EC2A 3AY |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 15065010840024 | CADDIE - CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure.The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas).CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope.The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement. | 9999999999 | cs@odin-vision.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 333212 | 1615294370 | K260133 | CADDIE | QNP | 2026-09-12 |
| 333212 | 1358034184 | K252586 | CADDIE | QNP | 2025-09-12 |
| 333212 | 1883270776 | K240044 | CADDIE | QNP | 2024-07-24 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QNP | 3 | 2026-09-12 |
PMN#
GUDID#
CADDIE - CADDIE is cloud based artificial intelligence medical device standalone software. CADDIE interfaces with the video feed generated by an endoscopic video processor during colonoscopy. CADDIE also includes a Cecum AI feature as an additional convenience function that prompts the user to verify that the CADDIE detection mode is enabled before inspection begins. The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas). CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope. The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user.
2026-10-01
CADDIE - CADDIE is cloud based artificial intelligence medical device standalone software. CADDIE interfaces with the video feed generated by an endoscopic video processor during colonoscopy. CADDIE also includes a Cecum AI feature as an additional convenience function that prompts the user to verify that the CADDIE detection mode is enabled before inspection begins. The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas). CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope. The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user.
2025-10-16
CADDIE - CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure.The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas).CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope.The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement.
2024-10-01