Rmi Short Distance Alignment Device
FDA 510(k) K885223 · Radiation Measurements, Inc.
510(k) numberK885223
Submission
- Device name
- Rmi Short Distance Alignment Device
- Applicant
- Radiation Measurements, Inc.
Middleton, WI, US - Received
- December 20, 1988
- Decision date
- February 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K893216 | Rmi Ultrasound Doppler Phantom SystemGXX · Traditional | 09/05/1989SE |
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| K834482 | Tissue Mimicking Ultrasound PhantomsIXF · Traditional | 01/25/1984SE |
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| K837033 | Rotatable Half Beam Shielding Block Model 440 · Traditional | 03/09/1983SE |
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Questions and answers
When was Rmi Short Distance Alignment Device cleared by the FDA?
Rmi Short Distance Alignment Device (K885223) received a 510(k) decision of Substantially Equivalent on February 17, 1989, 59 days after the submission was received.
What is the product code of K885223?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.