Pegasus
FDA 510(k) K935009 · Advanced Technology Laboratories, Inc.
510(k) numberK935009
Submission
- Device name
- Pegasus
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- October 20, 1993
- Decision date
- October 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
More from Beijing Konted Medical Technology Co.,Ltd
| 510(k) | Device | Decision |
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| K021966 | Q Lab SoftwareLLZ · Traditional | 07/02/2002SE |
| K011224 | Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and…IYN · Traditional | 05/04/2001SE |
| K002144 | Medlink Diagnostic Offline WorkstationLLZ · Traditional | 09/28/2000SE |
| K992470 | Ultramark 400C/SONOACE 6000 Ultrasound SystemIYO · Traditional | 08/23/1999SE |
| K991671 | Hdi 5000 Diagnostic Ultrasound SystemIYO · Traditional | 06/18/1999SE |
| K961459 | Level 10 HdiIYO · Traditional | 03/26/1997SE |
| K940423 | Nova Microsonics Access Image Management Network/Access Acquisition ModuleLMD · Traditional | 07/29/1994SE |
| K905248 | Nova Microsonics Capricorn Digital Image SystemsDQK · Traditional | 02/28/1991SE |
| K903603 | Ultramark 9 Ultrasound System (Um 9)IYO · Traditional | 02/26/1991SE |
| K901329 | Cephalic Doppler W/Ultramark 9 Ultrasound SystemIYN · Traditional | 11/23/1990SE |
Questions and answers
When was Pegasus cleared by the FDA?
Pegasus (K935009) received a 510(k) decision of Substantially Equivalent on October 11, 1994, 356 days after the submission was received.
What is the product code of K935009?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.