DeviceSignal · 510(k) cleared
Heartvue.ai, Inc.
FDA 510(k) decision recorded 2026-08-26 · K260811 · Traditional 510(k)
Event510(k) cleared
Effective2026-08-26
DecisionSESE
On 2026-08-26 the FDA recorded a 510(k) clearance decision for Heartvue.ai, Inc., for Heartvue.Proton. Clearance K260811. Product code QIH. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K260811
- Applicant
- Heartvue.ai, Inc.
- Device
- Heartvue.Proton
- Decided on
- 2026-08-26
- Received on
- 2026-03-12
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- QIH
- Review days
- 167
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K260811- Snapshot hash
a17b676375c92ad46cfd0c81b2c18852150764f05c544c0889e193548d652e00- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
263ebf3b6e8d2327ac957b88ab3b2ae96d39a1fc5eb4c9bcf7d6e8e8b51e3b38- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)