System, Echo, Pulsed Ultrasonic Diag
510(k) K802708
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK802708 | Date7 Jan 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
An ultrasonic pulsed echo imaging system is a device that projects a pulsed sound beam into body tissue to determine the depth or location of tissue interfaces and measures the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This device may include signal analysis and display equipment, patient and transducer interfaces, and accessories.
The system is manufactured by General Electric Co. and is supplied as a Class II device with special controls. It received FDA 510(k) clearance on January 7, 1981, with the product code IYO. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.
Other devices from General Electric Co.
Questions
AI-generated answers, 1 Oct 2026
What is the purpose of the Pulsed Ultrasonic Echo Imaging System?
This system projects a pulsed sound beam into body tissue to determine the depth or location of tissue interfaces. It measures the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver, and includes signal analysis and display equipment.
How is the Pulsed Ultrasonic Echo Imaging System supplied?
The system is supplied as a Class II device with special controls. It includes the main device, signal analysis and display equipment, patient and transducer interfaces, and various accessories. No information is provided regarding whether it is single-use or reusable.
What regulatory status does the Pulsed Ultrasonic Echo Imaging System have?
The device received FDA 510(k) clearance on January 7, 1981, with the product code IYO. It is classified as a Class II device with special controls and was determined to be substantially equivalent to other legally marketed devices.
Are there any specific storage conditions required for this device?
No information regarding storage conditions is provided in the device data. The manufacturer is General Electric Co., located in McHenry, IL, but specific storage requirements are not specified in the documentation.