Model SR-115 Portable X-Ray System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K052001 FDA 510(k)
- FDA Product Code
- IZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1720 FDA 510(k)
- Regulation Number
- 892.1720 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model SR-115 Portable X-Ray System is a mobile X-ray system designed for diagnostic imaging. It is classified as a Class II medical device under FDA regulation 892.1720 and has received FDA 510(k) clearance under K052001, determined to be substantially equivalent to a predicate device.
The system is intended for use in radiology settings and is supplied as a non-sterile, reusable device. It requires standard storage conditions and is not indicated for MRI environments. Authorizations include FDA 510(k) clearance, with no additional sterility, single-use, or MRI safety claims provided in the data.
Frequently asked questions
What is the SR-115 Portable X-Ray System used for?
The SR-115 Portable X-Ray System is used for diagnostic imaging in radiology settings.
Is the SR-115 Portable X-Ray System sterile?
The SR-115 Portable X-Ray System is supplied as a non-sterile device.
Can the SR-115 Portable X-Ray System be used in MRI environments?
No, the SR-115 Portable X-Ray System is not indicated for use in MRI environments.
How is the SR-115 Portable X-Ray System stored?
The SR-115 Portable X-Ray System requires standard storage conditions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Claude Haiku 4.5 System Card, Claude Sonnet 4.6 System Card, Handout_Ising-2.pdf - Heidelberg University
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052001 | Class II | Active |
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Manufacturer
- Manufacturer
- Source-Ray, Inc.
Sources (1)
- FDA 510(k) K052001 24 fields · synced Sep 23, 2026