Prostate Spectroscopy and Imaging Exam (Prose) Software Option for MRI
FDA 510(k) K011604 · Ge Medical Systems, Inc.
510(k) numberK011604
Submission
- Device name
- Prostate Spectroscopy and Imaging Exam (Prose) Software Option for MRI
- Applicant
- Ge Medical Systems, Inc.
Milwaukee, WI, US - Received
- May 24, 2001
- Decision date
- August 22, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Prostate Spectroscopy and Imaging Exam (Prose) Software Option for MRI cleared by the FDA?
Prostate Spectroscopy and Imaging Exam (Prose) Software Option for MRI (K011604) received a 510(k) decision of Substantially Equivalent on August 22, 2001, 90 days after the submission was received.
What is the product code of K011604?
The FDA product code is LNI – System, Nuclear Magnetic Resonance Spectroscopic, a Class II (moderate risk) device regulated under 21 CFR 892.1000.