Imris Oncology Package
FDA 510(k) K121997 · Imris, Inc.
510(k) numberK121997
Submission
- Device name
- Imris Oncology Package
- Applicant
- Imris, Inc.
Winnipeg, Mb, CA - Received
- July 9, 2012
- Decision date
- August 10, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Imris Oncology Package cleared by the FDA?
Imris Oncology Package (K121997) received a 510(k) decision of Substantially Equivalent on August 10, 2012, 32 days after the submission was received.
What is the product code of K121997?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.