HERA Z20 Diagnostic Ultrasound System +5 more— 510(k) K252018
Substantially EquivalentSamsung Medison Co., Ltd.
FDA 510(k) clearance K252018 for HERA Z20 Diagnostic Ultrasound System +5 more, Substantially Equivalent on 2026-01-05. Applicant: Samsung Medison Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
- Applicant
- Samsung Medison Co., Ltd.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hongcheon-Gun, KR
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More clearances from Samsung Medison Co., Ltd.
view all- K261412 — V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System +4 more
- K254099 — EVO Q30 Diagnostic Ultrasound System +8 more
- K250999 — V8 Diagnostic Ultrasound System +9 more
- K243702 — V8 Diagnostic Ultrasound System +5 more
- 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
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.