Optima XR646 HD— 510(k) K173612
Substantially EquivalentGe Hualun Medical Systems Co. , Ltd.
FDA 510(k) clearance K173612 for Optima XR646 HD, Substantially Equivalent on 2017-12-11. Applicant: Ge Hualun Medical Systems Co. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Ge Hualun Medical Systems Co. , Ltd.
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Beijing, CN
Recent devices under product code KPR
view allMore clearances from Ge Hualun Medical Systems Co. , Ltd.
view allAdverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
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 K173612
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173612.
Data sourced from openFDA. This site is unofficial and independent of the FDA.