SSD-240 Ultrasonic Scanner
by U. S. A. Imaging Corp. 510(k)
Active
510(k) K813397
Overview
The SSD-240 Ultrasonic Scanner is a System, Imaging, Pulsed Echo, Ultrasonic device, classified under FDA product code IYO. It generates and interprets high-frequency sound waves to create visual images of internal body structures, primarily used in radiology for diagnostic purposes.
This scanner is intended for use in clinical radiology settings and was granted FDA 510(k) clearance (K813397) under the Substantially Equivalent (SESE) determination in 1982. No specific sterility or single-use/reusable designation is noted in the data, though typical ultrasound systems of this era were often reusable with appropriate cleaning protocols. The device falls under FDA regulation 892.1560 and was reviewed by the Radiology Advisory Committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813397 | Date2 Mar 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from U. S. A. Imaging Corp.
Questions
What clinical setting is the SSD-240 Ultrasonic Scanner designed for, and how does its FDA clearance relate to its use?
The SSD-240 Ultrasonic Scanner is specifically intended for use in clinical radiology settings, where it generates and interprets high-frequency sound waves to produce diagnostic images of internal body structures. Its FDA 510(k) clearance (K813397) under the Substantially Equivalent (SESE) determination in 1982 confirms it meets regulatory standards for safety and effectiveness as a pulsed-echo ultrasonic imaging system (product code IYO). This clearance does not restrict its use to any specific condition but validates its general application in radiology for diagnostic imaging purposes.
Is the SSD-240 Ultrasonic Scanner single-use or reusable, and what cleaning protocols should be followed?
The SSD-240 Ultrasonic Scanner is not explicitly designated as single-use or sterile in the provided data. Like many ultrasound systems from this era, it was likely designed for reuse with proper disinfection and maintenance protocols. Standard practices for reusable medical imaging devices—such as cleaning with approved disinfectants and following manufacturer guidelines—would apply to ensure hygiene and functionality.
What regulatory pathway did the SSD-240 Ultrasonic Scanner follow to gain FDA approval, and which committee reviewed it?
The SSD-240 Ultrasonic Scanner received FDA clearance through the Traditional 510(k) pathway, submitted by U.S.A. Imaging Corp. in December 1981. The device was reviewed by the Radiology Advisory Committee (RA), which evaluated its equivalence to predicate devices under the Substantially Equivalent (SESE) determination. The clearance (K813397) was granted on March 2, 1982, confirming compliance with FDA regulations for imaging systems (product code IYO).
How does the SSD-240’s classification under FDA product code IYO impact its intended use?
The SSD-240’s classification under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic) categorizes it as a diagnostic imaging device for generating and interpreting ultrasound images. This classification ensures it adheres to standards for pulsed-echo ultrasound systems, which are used to visualize internal structures like organs, blood flow, and tissues. While the code doesn’t specify exact clinical applications, it confirms the device’s role in radiology for diagnostic purposes.