Ischema View Rapid
FDA 510(k) K121447 · Ischemaview, Inc.
510(k) numberK121447
Submission
- Device name
- Ischema View Rapid
- Applicant
- Ischemaview, Inc.
Irvine, CA, US - Received
- May 15, 2012
- Decision date
- October 4, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ischema View Rapid cleared by the FDA?
Ischema View Rapid (K121447) received a 510(k) decision of Substantially Equivalent on October 4, 2013, 507 days after the submission was received.
What is the product code of K121447?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.