High-Speed Sector Scanning SSL-52H
510(k) K771292
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771292 | Date16 Aug 1977 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The High-Speed Sector Scanning SSL-52H is an Echocardiograph, a diagnostic ultrasound device designed for cardiovascular imaging. It employs sector scanning technology to produce real-time visualizations of the heart, enabling clinicians to assess cardiac structure and function. This device falls under the classification of Class II medical devices, as defined by regulatory authorities, and is intended for use in echocardiography examinations. Its primary function is to generate detailed images of the heart chambers, valves, and surrounding tissues for diagnostic purposes.
The SSL-52H is supplied as a reusable medical device and is intended for use in clinical settings such as hospitals and cardiac care units. It operates under sterile conditions when in direct contact with patients, adhering to standard infection control protocols. The device is authorized for use in the United States following FDA 510(k) clearance under the Traditional review pathway, with a decision date of August 16, 1977. No specific MRI safety information is provided, and its regulatory status is tied to the DXK product code, categorized under the Cardiovascular medical specialty. Storage and maintenance instructions are not detailed in the available data.
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Questions
AI-generated answers, 1 Oct 2026
What is the SSL-52H used for in clinical practice?
The SSL-52H is an echocardiograph designed specifically for cardiovascular imaging. It uses sector scanning technology to provide real-time visualizations of the heart, allowing clinicians to evaluate cardiac structures such as chambers, valves, and surrounding tissues. This helps in diagnosing and monitoring heart conditions by offering clear, detailed images for assessment.
Is the SSL-52H a single-use or reusable device?
The SSL-52H is a reusable medical device, intended for use in clinical environments like hospitals and cardiac care units. Reusability is common for high-end diagnostic equipment to ensure durability and cost-effectiveness, though proper sterilization and maintenance protocols must be followed to prevent infection and ensure device integrity.
How is sterility maintained when using the SSL-52H?
The SSL-52H must be handled under sterile conditions whenever it comes into direct contact with patients. This follows standard infection control protocols to minimize the risk of cross-contamination. The device’s reusable nature requires adherence to rigorous cleaning, disinfection, and sterilization procedures between uses to maintain safety and functionality.
What regulatory pathway was followed for FDA clearance of the SSL-52H?
The SSL-52H received FDA 510(k) clearance under the Traditional review pathway, with a decision date of August 16, 1977. This pathway is used for devices that are substantially equivalent to a legally marketed predicate device. The clearance was tied to the DXK product code, categorized under the Cardiovascular specialty, confirming its classification as a Class II medical device.
Are there any specific storage or maintenance instructions for the SSL-52H?
While the provided data does not detail specific storage or maintenance instructions, reusable medical devices like the SSL-52H generally require proper environmental conditions to prevent damage. This includes protection from extreme temperatures, humidity, and physical stress. Regular calibration and servicing by trained technicians are also essential to ensure optimal performance and longevity of the device.