Imagefusion 2.0
FDA 510(k) K990071 · Radionics, Inc.
510(k) numberK990071
Submission
- Device name
- Imagefusion 2.0
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- January 11, 1999
- Decision date
- February 8, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Imagefusion 2.0 cleared by the FDA?
Imagefusion 2.0 (K990071) received a 510(k) decision of Substantially Equivalent on February 8, 1999, 28 days after the submission was received.
What is the product code of K990071?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.