Is SleepImage System FDA approved or cleared?
Yes. SleepImage System by MyCardio LLC (SleepImage) is named in the FDA register with a 510(k) clearance, first authorised in 2009, latest decision in 2019.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | SleepImage System |
|---|---|
| Maker | MyCardio LLC (SleepImage) |
| Care area | Sleep & breathing |
| What it does | Software that analyses sleep from a finger sensor and app, used by clinicians to evaluate sleep and sleep apnea at home |
| FDA | 510(k), latest decision 2019 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | sleepimage.com |
| Status | FDA verified |
| Last checked | 15 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Other apps in Sleep & breathing
- AcuPebble™ Ox100
- Aevice Wheeze Detection Module
- AeviceMD
- AireHealth Nebulizer
- ANNE Sleep
- Apple Watch Sleep Apnea Notifications
- Belun Ring
- CapMedic