Radiological Image Processing System
FDA 510(k) K102078 · VATECH Co., Ltd.
510(k) numberK102078
Submission
- Device name
- Radiological Image Processing System
- Applicant
- VATECH Co., Ltd.
Secaucus, NJ, US - Received
- July 26, 2010
- Decision date
- August 10, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Radiological Image Processing System cleared by the FDA?
Radiological Image Processing System (K102078) received a 510(k) decision of Substantially Equivalent on August 10, 2011, 380 days after the submission was received.
What is the product code of K102078?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.