DeviceSignal · 510(k) cleared
Samsung Medison Co., Ltd.
FDA 510(k) decision recorded 2026-07-28 · K261412 · Traditional 510(k)
Event510(k) cleared
Effective2026-07-28
DecisionSESE
On 2026-07-28 the FDA recorded a 510(k) clearance decision for Samsung Medison Co., Ltd., for V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…. Clearance K261412. Product code IYN. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K261412
- Applicant
- Samsung Medison Co., Ltd.
- Device
- V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;
- Decided on
- 2026-07-28
- Received on
- 2026-04-30
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- IYN
- Review days
- 89
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K261412- 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
fdc320ca649d2d145d7825824323eef3531f6455664348de8a6da81b70888c1b- 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)