(68 days)
The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.
Not Found
I am sorry, but the provided text does not contain the detailed information about the acceptance criteria, device performance, or the specific study details that you requested. The document is a 510(k) clearance letter from the FDA for an "RC-115 Optional Remote Control (accessory to SR-115 Portable X-ray System)". It states that the device is substantially equivalent to legally marketed predicate devices.
The letter explicitly focuses on:
- Approval of marketing: It grants permission to market the device based on substantial equivalence.
- Regulatory classification: It identifies the device as Class II with product code IZL and regulation number 21 CFR 892.1720 (Mobile x-ray system).
- General regulatory requirements: It reminds the applicant about various FDA regulations they must comply with (registration, listing, labeling, good manufacturing practice, electronic product radiation control).
- Indications for Use: The portable X-ray system is intended for "General Purpose Portable Radiographic Applications."
It does not provide:
- A table of acceptance criteria or reported device performance.
- Details about specific studies, sample sizes, data provenance, or ground truth establishment.
- Information on expert reconciliation, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill your request for these specifics based on the input provided.
§ 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.