DLX
FDA 510(k) K926258 · GE Medical Systems
510(k) numberK926258
Submission
- Device name
- DLX
- Applicant
- GE Medical Systems
Milwaukee, WI, US - Received
- December 18, 1992
- Decision date
- March 15, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)IZI · Traditional | Carl Zeiss Meditec, Inc. | 06/20/2023SE |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional | Novadaq Technologies Ulc (A Part of Stryker) | 06/05/2023SE |
| K222240 | Explorer Air® IIIZI · Traditional | Surgvision GmbH | 02/28/2023SE |
| K214097 | Explorer Air IIIZI · Traditional | Surgvision GmbH | 02/25/2022SE |
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|---|---|---|
| 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 DLX cleared by the FDA?
DLX (K926258) received a 510(k) decision of Substantially Equivalent on March 15, 1993, 87 days after the submission was received.
What is the product code of K926258?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.