General Ultrasound Exam. Table
FDA 510(k) K802254 · Engineering Dynamics Corp.
510(k) numberK802254
Submission
- Device name
- General Ultrasound Exam. Table
- Applicant
- Engineering Dynamics Corp.
Mchenry, IL, US - Received
- September 16, 1980
- Decision date
- November 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K834098 | Stationary Exercise BicycleISD · Traditional | 12/27/1983SE |
| K828313 | Digital Radiography Examination Table · Traditional | 10/07/1982SE |
| K790545 | Stress Testing System, Lateral TiltingDRT · Traditional | 06/06/1979SE |
| K790544 | Stress Testing System, Multi-PositionDRT · Traditional | 06/05/1979SE |
| K790466 | U-MatIYX · Traditional | 03/28/1979SE |
| K790499 | Multiple Pinhole Tomographic CollimoterIYX · Traditional | 03/26/1979SE |
Questions and answers
When was General Ultrasound Exam. Table cleared by the FDA?
General Ultrasound Exam. Table (K802254) received a 510(k) decision of Substantially Equivalent on November 26, 1980, 71 days after the submission was received.
What is the product code of K802254?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.