FDA 510(k) K241108, RemedyLogic AI MRI Lumbar Spine Reader, by Remedy Logic, Inc.
FDA 510(k) K241108, RemedyLogic AI MRI Lumbar Spine Reader, by Remedy Logic, Inc.
| 510(k) Number | K241108 |
| Device Classification Name | Automated Radiological Image Processing Software |
| Device Name | RemedyLogic AI MRI Lumbar Spine Reader |
| Applicant | Remedy Logic, Inc. 1177 Ave. Of The Americas, 5th Floor New York, NY 10036 |
| Regulation Number | 892.205 |
| Classification Product Code | QIH |
| Date Received | 04/22/2024 |
| Decision Date | 10/30/2024 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 1629 |
| Redacted Pages | 991 |
| Unredacted Pages | 638 |
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