FCR Go Portable Digital X-Ray System
FDA 510(k) K080945 · Fujifilm Medical Systems U.S.A, Inc.
510(k) numberK080945
Submission
- Device name
- FCR Go Portable Digital X-Ray System
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
Stamford, CT, US - Received
- April 3, 2008
- Decision date
- April 18, 2008
- 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 FCR Go Portable Digital X-Ray System cleared by the FDA?
FCR Go Portable Digital X-Ray System (K080945) received a 510(k) decision of Substantially Equivalent on April 18, 2008, 15 days after the submission was received.
What is the product code of K080945?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.