Digital Radiography System with Flat Panel Detector, Model DFP8000D
FDA 510(k) K041027 · Toshibamedical Systems Corporation
510(k) numberK041027
Submission
- Device name
- Digital Radiography System with Flat Panel Detector, Model DFP8000D
- Applicant
- Toshibamedical Systems Corporation
Tustin, CA, US - Received
- April 21, 2004
- Decision date
- May 14, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Digital Radiography System with Flat Panel Detector, Model DFP8000D cleared by the FDA?
Digital Radiography System with Flat Panel Detector, Model DFP8000D (K041027) received a 510(k) decision of Substantially Equivalent on May 14, 2004, 23 days after the submission was received.
What is the product code of K041027?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.