MRI Patient Positioning Devices
FDA 510(k) K093738 · Medtec, Inc.
510(k) numberK093738
Submission
- Device name
- MRI Patient Positioning Devices
- Applicant
- Medtec, Inc.
Kalona, IA, US - Received
- December 4, 2009
- Decision date
- May 14, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was MRI Patient Positioning Devices cleared by the FDA?
MRI Patient Positioning Devices (K093738) received a 510(k) decision of Substantially Equivalent on May 14, 2010, 161 days after the submission was received.
What is the product code of K093738?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.