Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
FDA 510(k) K191777 · Ge Medical Systems, LLC
510(k) numberK191777
Submission
- Device name
- Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- Applicant
- Ge Medical Systems, LLC
Waukesha, WI, US - Received
- July 2, 2019
- Decision date
- July 26, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
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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 |
|---|---|---|
| K253808 | AIR Recon DLLNH · Traditional | 08/13/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | 06/24/2026SE |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI AlgorithmQIH · Traditional | 04/14/2026SE |
| K253520 | Photonova Spectra, Photonova Spectra SelectJAK · Traditional | 03/20/2026SE |
| K253780 | SIGNA BoltLNH · Traditional | 02/06/2026SE |
| K253779 | SIGNA Sprint SelectLNH · Traditional | 02/05/2026SE |
| K252379 | AIR Recon DLLNH · Traditional | 12/23/2025SE |
| K251399 | SIGNA SprintLNH · Traditional | 09/11/2025SE |
| K250941 | Revolution VibeJAK · Traditional | 08/01/2025SE |
| K243667 | Sonic DLLNH · Traditional | 06/05/2025SE |
Questions and answers
When was Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition cleared by the FDA?
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition (K191777) received a 510(k) decision of Substantially Equivalent on July 26, 2019, 24 days after the submission was received.
What is the product code of K191777?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.