3 devices · 3 companies · 2024 to 2025
Product code SDJ: Adjunctive Cardiac Amyloidosis Status Indicator
3 devices under product code SDJ, 2024 to 2025, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Adjunctive Cardiac Amyloidosis Status Indicator. 21 CFR 870.2200, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Us2.caK250151 · 510(k) | Eko.Ai Pte Ltd. D/B/A Us2.Ai | Cardiovascular | database entry | |
| InVision Precision Cardiac AmyloidK243866 · 510(k) | InVision Medical Technology Corporation | Cardiovascular | database entry | |
| EchoGo AmyloidosisK240860 · 510(k) | Ultromics Limited | Cardiovascular | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.