510(k)
K242511: V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System
FDA 510(k) · Samsung Medison Co., Ltd. · decided Dec 10, 2024
Key facts
| 510(k) number | K242511 |
|---|---|
| Device name | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System |
| Applicant | Samsung Medison Co., Ltd. |
| Product code | IYN |
| Subsequent product codes | ITX, IYO, QIH |
| Date received | Aug 23, 2024 |
| Decision date | Dec 10, 2024 |
| Decision | Substantially equivalent (SESE) |
| Submission type | Traditional |
| Review panel | Radiology |
| Medical specialty | Radiology |
At a glance
- None MAUDE adverse event reports
- None Recall events
- 1–9 UDI device identifiers (GUDID)
- 1–9 Predicate devices cited
- 1–9 Later submissions citing this device
- 1,000+ 510(k)s with this product code
- Yes 510(k) summary on file
- No 510(k) statement on file
- Listed On the FDA AI-enabled device list
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
Reading a 510(k)
- Decision
- SESE means the FDA found the device substantially equivalent to its predicate, so it may be marketed in the United States.
- Predicates
- Each clearance cites one or more legally marketed devices; the chain of predicates shows where a technology came from.
- Product code
- The three-letter code sets the device type, class and regulation, and groups competing clearances.
- Summary or statement
- Applicants file either a 510(k) summary of the safety and effectiveness information or a statement that it is available on request.
About 510(k) premarket notifications
A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Source: U.S. Food and Drug Administration (FDA), 510(k) Premarket Notification database · Source date: