GM60A-32S, GM60A-40S— 510(k) K142492
Substantially EquivalentSamsung Electronics Co., Ltd.
FDA 510(k) clearance K142492 for GM60A-32S, GM60A-40S, Substantially Equivalent on 2014-12-17. Applicant: Samsung Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Samsung Electronics Co., Ltd.
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suwon-Si, Gyeonggi-Do, KR
Recent devices under product code IZL
view allMore clearances from Samsung Electronics Co., Ltd.
view allAdverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
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 →
Recalls naming K142492
K-number listed on FDA's recall record- Z-0263-2016 — Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142492.
Data sourced from openFDA. This site is unofficial and independent of the FDA.