3D/5D Viewer— 510(k) K151808
Substantially EquivalentSamsung Medison Co., Ltd.
FDA 510(k) clearance K151808 for 3D/5D Viewer, Substantially Equivalent on 2015-07-29. Applicant: Samsung Medison Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Samsung Medison Co., Ltd.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gangnam-Gu, KR
Recent devices under product code LLZ
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- K254099 — EVO Q30 Diagnostic Ultrasound System +8 more
- K252018 — HERA Z20 Diagnostic Ultrasound System +5 more
- K250999 — V8 Diagnostic Ultrasound System +9 more
- K243702 — V8 Diagnostic Ultrasound System +5 more
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.