DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000— 510(k) K092830
Substantially EquivalentVATECH Co., Ltd.
FDA 510(k) clearance K092830 for DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000, Substantially Equivalent on 2010-07-21. Applicant: VATECH Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- VATECH 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
- Traditional
- Location
- Houston, TX, US
Recent devices under product code KPR
view allMore clearances from VATECH 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 →
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