GE Logiq 7 Ultrasound BT05
FDA 510(k) K052441 · General Electric Co.
510(k) numberK052441
Submission
- Device name
- GE Logiq 7 Ultrasound BT05
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- September 6, 2005
- Decision date
- September 21, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261313 | Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 09/02/2026SE |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional | Sonoscape Medical Corp. | 08/24/2026SE |
| K261668 | Venue GoIYN · Traditional | GE Medical Systems Ultrasound and Primary care… | 08/07/2026SE |
| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 08/04/2026SE |
| K261835 | LOGIQ FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/30/2026SE |
| K261288 | Handheld Ultrasound ScannerIYN · Traditional | Imgfax Co., Ltd. | 07/30/2026SE |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional | Samsung Medison Co., Ltd. | 07/28/2026SE |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | Philips Ultrasound, LLC | 07/27/2026SE |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 07/23/2026SE |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
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| 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 GE Logiq 7 Ultrasound BT05 cleared by the FDA?
GE Logiq 7 Ultrasound BT05 (K052441) received a 510(k) decision of Substantially Equivalent on September 21, 2005, 15 days after the submission was received.
What is the product code of K052441?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.