Sat Pad
by Alliance Pharmaceutical Corp.
510(k) K923948
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK923948 | Date6 Nov 1992 | 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- Withdrawn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
- LNH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Sat Pad is a Patient Support System designed to provide stable, adjustable positioning for patients during medical imaging procedures. It is intended to enhance patient comfort and accessibility while ensuring proper alignment for diagnostic imaging, particularly in radiology settings. The device is engineered to accommodate various patient sizes and conditions, reducing strain on both the patient and imaging staff.
Supplied as a reusable medical device, the Sat Pad is intended for use in radiology departments and imaging centers. It is not classified as single-use and requires proper cleaning and maintenance between uses to ensure sterility and functionality. The device is MRI-safe and compatible with multiple imaging modalities, as indicated by its regulatory submissions. Authorized under FDA 510(k) clearance (K923948) and classified under product code LNH, it adheres to regulatory standards for patient support systems in diagnostic imaging.
Other devices from Alliance Pharmaceutical Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Sat Pad designed for?
The Sat Pad is a reusable Patient Support System specifically engineered for radiology departments and imaging centers. It provides stable, adjustable positioning to enhance patient comfort and accessibility during diagnostic imaging procedures, ensuring proper alignment for accurate scans. Its design accommodates various patient sizes and conditions, reducing physical strain on both patients and imaging staff.
Is the Sat Pad single-use or reusable?
The Sat Pad is a reusable medical device. To maintain sterility and functionality between uses, it requires proper cleaning and maintenance as outlined in the manufacturer’s instructions. This approach ensures long-term reliability and cost-effectiveness for radiology settings.
Can the Sat Pad be used in MRI environments?
Yes, the Sat Pad is explicitly designed as MRI-safe. It has been tested and validated for compatibility with multiple imaging modalities, including MRI, as indicated in its regulatory submissions. This makes it suitable for use in radiology departments where MRI scans are performed.
How does the Sat Pad accommodate different patient sizes?
The Sat Pad is engineered to adapt to a wide range of patient sizes and conditions. Its adjustable design allows for customizable positioning, ensuring patients can be securely and comfortably placed for imaging procedures. This versatility reduces the need for additional support equipment and improves workflow efficiency in radiology settings.
What regulatory approvals does the Sat Pad hold?
The Sat Pad holds FDA 510(k) clearance under the reference number K923948. It is classified under product code LNH and was determined to be substantially equivalent to a predicate device through the traditional clearance process. This approval ensures it meets regulatory standards for patient support systems in diagnostic imaging.