Wireless Portable Detector FD-W17
FDA 510(k) K090625 · Philips Medical Systems North America Co.
510(k) numberK090625
Submission
- Device name
- Wireless Portable Detector FD-W17
- Applicant
- Philips Medical Systems North America Co.
Bothell, WA, US - Received
- March 9, 2009
- Decision date
- March 24, 2009
- 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 Wireless Portable Detector FD-W17 cleared by the FDA?
Wireless Portable Detector FD-W17 (K090625) received a 510(k) decision of Substantially Equivalent on March 24, 2009, 15 days after the submission was received.
What is the product code of K090625?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.