K243866 is an FDA 510(k) clearance for the InVision Precision Cardiac Amyloid. This device is classified as a Adjunctive Cardiac Amyloidosis Status Indicator (Class II - Special Controls, product code SDJ).
Submitted by Invision Medical Technology Corporation (Los Angeles, US). The FDA issued a Cleared decision on May 21, 2025, 155 days after receiving the submission on December 17, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2200. The Adjunctive Cardiac Amyloidosis Status Indicator Is A Prescription Device Based On Sensor Technology Or Image Data To Provide Information To An Interpreting Clinician In Detecting Cardiac Amyloidosis. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy..
| 510(k) Number | K243866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2024 |
| Decision Date | May 21, 2025 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | SDJ - Adjunctive Cardiac Amyloidosis Status Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2200 |
| Definition | The Adjunctive Cardiac Amyloidosis Status Indicator Is A Prescription Device Based On Sensor Technology Or Image Data To Provide Information To An Interpreting Clinician In Detecting Cardiac Amyloidosis. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy. |