A Breast Coil for the Gyrex 2T-DIX
FDA 510(k) K923897 · Elscint, Inc.
510(k) numberK923897
Submission
- Device name
- A Breast Coil for the Gyrex 2T-DIX
- Applicant
- Elscint, Inc.
Hackensack, NJ, US - Received
- August 4, 1992
- Decision date
- October 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Canon Medical Systems Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K983313 | Advanced Automatic Detector Selection Option for GloryIZH · Traditional | 12/11/1998SE |
| K982060 | Volumax CT Imaging SystemJAK · Traditional | 09/02/1998SE |
| K974344 | CT ScopeJAK · Traditional | 06/03/1998SE |
| K980306 | Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EpLNH · Traditional | 04/02/1998SE |
| K974614 | Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1TG…LNH · Traditional | 03/04/1998SE |
| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)MOS · Traditional | 09/15/1997SE |
| K970680 | GloryIZH · Traditional | 06/20/1997SE |
| K965044 | Gyrex 2T Prestige Model No. 100-6321-0107 and Gyrex Privilege Model No. 100-6326-0102LNH · Traditional | 06/16/1997SE |
| K970980 | Cardiac Scoring for CT ScannersJAK · Traditional | 05/29/1997SE |
| K970005 | Gyrex 2T-PRESTIGELNI · Traditional | 03/28/1997SE |
Questions and answers
When was A Breast Coil for the Gyrex 2T-DIX cleared by the FDA?
A Breast Coil for the Gyrex 2T-DIX (K923897) received a 510(k) decision of Substantially Equivalent on October 21, 1992, 78 days after the submission was received.
What is the product code of K923897?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.