Unix-Link
FDA 510(k) K926550 · General Electric Co.
510(k) numberK926550
Submission
- Device name
- Unix-Link
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- December 31, 1992
- Decision date
- March 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K160933 | Discovery NM 750b BopsyIYX · Traditional | GE Healthcare | 11/18/2016SE |
| K162052 | Sentinella 102, Sentinella 102 HorusIYX · Special | General Equipment For Medical Imaging (Oncovision- | 08/18/2016SE |
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| K123408 | Ergo Imaging SystemIYX · Traditional | Digirad Corp. | 01/15/2013SE |
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| K082317 | GE Lunar Frax 10-YEAR Fracture Risk Software OptionKGI · Traditional | 09/26/2008SE |
| K081921 | GE Vivid E9 UltrasoundIYN · Special | 08/06/2008SE |
| K073297 | GE Logiq P6IYN · Special | 12/18/2007SE |
| K072952 | GE EchopacLLZ · Special | 11/16/2007SE |
| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
| K072075 | Modification to GE Logiq A3IYN · Special | 08/29/2007SE |
| K071985 | GE Vivid S5 and S6 Diagnostic UltrasoundIYN · Special | 08/17/2007SE |
Questions and answers
When was Unix-Link cleared by the FDA?
Unix-Link (K926550) received a 510(k) decision of Substantially Equivalent on March 18, 1993, 77 days after the submission was received.
What is the product code of K926550?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.