K240860 is an FDA 510(k) clearance for the EchoGo Amyloidosis (1.0). This device is classified as a Adjunctive Cardiac Amyloidosis Status Indicator (Class II - Special Controls, product code SDJ).
Submitted by Ultromics Limited (Oxford, GB). The FDA issued a Cleared decision on November 15, 2024, 232 days after receiving the submission on March 28, 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 | K240860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2024 |
| Decision Date | November 15, 2024 |
| Days to Decision | 232 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. |