SR-130

• K Number: K030494
• Device Name: SR-130
• Manufacturer: SOURCE-RAY, INC.
• Date Cleared: 2003-05-20 ( 90 days)
• Product Code: IZL
• Regulation Number: 892.1720
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

The Model SR-130 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a portable X-ray system (SR-130). This type of letter does not contain details about acceptance criteria, device performance studies, or ground truth establishment.

The letter is a regulatory document stating that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It focuses on regulatory compliance, classification, and general controls, rather than detailed performance study results.

Therefore, I cannot provide the requested information based on the input text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies or human reader improvement with AI.
6. Results from standalone algorithm performance studies.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.