ACU-RAY HF SERIES PORTABLE X-RAY UNIT

• K Number: K972204
• Device Name: ACU-RAY HF SERIES PORTABLE X-RAY UNIT
• Manufacturer: STERNE EQUIPMENT CO., LTD.
• Date Cleared: 1997-10-08 ( 118 days)
• Product Code: IZL
• Regulation Number: 892.1720
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

GENERAL RADIOGRAPHIC MEDICAL X-RAY PROCEDURES

Device Description

STERNE ACU-RAY HF

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "STERNE ACU-RAY HF Series Portable X-Ray Unit". It states that the device is substantially equivalent to legally marketed predicate devices for general radiographic medical X-ray procedures.

However, this document does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications that would be required to answer the requested questions.

The letter is simply an FDA clearance notice, confirming that the device can be legally marketed. It does not include the technical details or study results that would typically be found in a submission to demonstrate substantial equivalence.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and the study proving device performance based on the input text.

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.