Adjunctive Cardiac Amyloidosis Status Indicator
SDJ is the FDA product code for Adjunctive Cardiac Amyloidosis Status Indicator, a class II device type, regulated under 21 CFR 870.2200. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SDJ
- Device name
- Adjunctive Cardiac Amyloidosis Status Indicator
- FDA 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.
- Regulation
- 21 CFR 870.2200
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code SDJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
| 2025 | 2 |
Applicants with the most clearances
Product code SDJ| Applicant | Clearances |
|---|---|
| Eko.Ai Pte Ltd. D/B/A Us2.Ai | 1 |
| Invision Medical Technology | 1 |
| Ultromics, Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.