FDA Product Code SDJ: Adjunctive Cardiac Amyloidosis Status Indicator
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.
Leading manufacturers include Ultromics Limited, Invision Medical Technology Corporation and Eko.Ai Pte Ltd. D/B/A Us2.Ai.
FDA 510(k) Cleared Adjunctive Cardiac Amyloidosis Status Indicator Devices (Product Code SDJ)
About Product Code SDJ - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code SDJ since 2024, with 3 receiving FDA clearance (average review time: 179 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SDJ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →