Autotune Device (Atd Ii)/Philips S-15/ACS MRI Scan
FDA 510(k) K932403 · Medrad, Inc.
510(k) numberK932403
Submission
- Device name
- Autotune Device (Atd Ii)/Philips S-15/ACS MRI Scan
- Applicant
- Medrad, Inc.
Indianola, PA, US - Received
- May 3, 1993
- Decision date
- February 24, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Autotune Device (Atd Ii)/Philips S-15/ACS MRI Scan cleared by the FDA?
Autotune Device (Atd Ii)/Philips S-15/ACS MRI Scan (K932403) received a 510(k) decision of Substantially Equivalent on February 24, 1994, 297 days after the submission was received.
What is the product code of K932403?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.