Mt/S Software Release 5.0.
FDA 510(k) K893518 · Diasonics, Inc.
510(k) numberK893518
Submission
- Device name
- Mt/S Software Release 5.0.
- Applicant
- Diasonics, Inc.
S. San Francisco, CA, US - Received
- May 8, 1989
- Decision date
- October 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code LNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260758 | MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional | Siemens Shenzhen Magnetic Resonance , Ltd. | 09/01/2026SE |
| K262622 | Swoop® Portable MR Imaging® SystemLNH · Special | Hyperfine, Inc. | 08/19/2026SE |
| K254250 | MagicScan-1.5, GreenMR Serenity 1.5TLNH · Traditional | Xingaoyi Medical Equipment Co.,Ltd | 08/17/2026SE |
| K253808 | AIR Recon DLLNH · Traditional | GE Medical Systems | 08/13/2026SE |
| K261331 | I-Genius (100019400)LNH · Traditional | Esaote, S.p.A. | 07/31/2026SE |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH · Traditional | Siemens Healthineers AG | 07/31/2026SE |
| K260113 | uMR AstraLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/22/2026SE |
| K253862 | APERTO Lucent MRI SystemLNH · Traditional | Fujifilm Corporation | 04/06/2026SE |
| K260746 | S-scan Open (100001800)LNH · Special | Esaote, S.p.A. | 03/27/2026SE |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional | Canon Medical Systems Corporation | 03/27/2026SE |
More from Canon Medical Systems Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K962662 | Vingmed Sound Color Flow Mapping SystemIYO · Traditional | 01/02/1997SE |
| K924079 | CFM-800 Color Flow Mapping SystemIYO · Traditional | 09/28/1993SE |
| 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 |
| K894290 | Access TMLNH · Traditional | 09/07/1989SE |
| K893881 | Access TMLNH · Traditional | 06/23/1989SE |
| K891452 | Spectra Ultrasound System W/Color Flow ModuleIYO · Traditional | 06/07/1989SE |
Questions and answers
When was Mt/S Software Release 5.0. cleared by the FDA?
Mt/S Software Release 5.0. (K893518) received a 510(k) decision of Substantially Equivalent on October 27, 1989, 172 days after the submission was received.
What is the product code of K893518?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.