Excel CT Twin
FDA 510(k) K915738 · Elscint, Inc.
510(k) numberK915738
Submission
- Device name
- Excel CT Twin
- Applicant
- Elscint, Inc.
Hackensack, NJ, US - Received
- December 20, 1991
- Decision date
- July 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
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| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
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| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 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 Excel CT Twin cleared by the FDA?
Excel CT Twin (K915738) received a 510(k) decision of Substantially Equivalent on July 21, 1992, 214 days after the submission was received.
What is the product code of K915738?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.