PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260

• K Number: K090655
• Device Name: PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260
• Manufacturer: SOURCE-RAY, INC.
• Date Cleared: 2009-07-14 ( 125 days)
• Product Code: IZL
• Regulation Number: 892.1720
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

The Model PowerMax 1260 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance), or training set information. The document is an FDA 510(k) clearance letter for the "PowerMax 1260 Portable X-Ray System," primarily confirming its substantial equivalence to predicate devices and outlining regulatory requirements. It includes an "Indications for Use" form, but this does not provide the specific details you requested regarding performance studies.

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.