Mt/S (Spine Transmit Coil)
FDA 510(k) K884606 · Diasonics, Inc.
510(k) numberK884606
Submission
- Device name
- Mt/S (Spine Transmit Coil)
- Applicant
- Diasonics, Inc.
S. San Francisco, CA, US - Received
- November 4, 1988
- Decision date
- December 5, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K253808 | AIR Recon DLLNH · Traditional | GE Medical Systems | 08/13/2026SE |
| K261331 | I-Genius (100019400)LNH · Traditional | Esaote, S.p.A. | 07/31/2026SE |
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| K260113 | uMR AstraLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/22/2026SE |
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| K260746 | S-scan Open (100001800)LNH · Special | Esaote, S.p.A. | 03/27/2026SE |
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| 510(k) | Device | Decision |
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| K962662 | Vingmed Sound Color Flow Mapping SystemIYO · Traditional | 01/02/1997SE |
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| K911435 | CPA/3.5 MHZ ProbeITX · Traditional | 09/11/1992SE |
| K905200 | Saca, 3.5 MHZ ProbeITX · Traditional | 04/02/1992SE |
| K903562 | CW Doppler 2.25 MHZ ProbeITX · Traditional | 03/02/1992SE |
| K903984 | CW DOPPLER/4.5 MHZITX · Traditional | 06/14/1991SE |
| K896637 | Access(Tm), Software Release 4.11PLPH · Traditional | 01/22/1990SE |
| K893518 | Mt/S Software Release 5.0.LNH · Traditional | 10/27/1989SE |
| K894290 | Access TMLNH · Traditional | 09/07/1989SE |
| K893881 | Access TMLNH · Traditional | 06/23/1989SE |
Questions and answers
When was Mt/S (Spine Transmit Coil) cleared by the FDA?
Mt/S (Spine Transmit Coil) (K884606) received a 510(k) decision of Substantially Equivalent on December 5, 1988, 31 days after the submission was received.
What is the product code of K884606?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.