(126 days)
The Soyee Portable X-Ray Unit Model SY-HF-110 is intended for portable and mobile general purpose diagnostic radiography in the field and clinic applications.
Not Found
This document is a 510(k) clearance letter for the Soyee Portable X-Ray Unit Model SY-HF-110, indicating substantial equivalence to a legally marketed predicate device.
Therefore, the letter does not contain details about specific acceptance criteria, device performance metrics, or a study that proves the device meets such criteria. Instead, the 510(k) process relies on demonstrating that the new device is as safe and effective as an already cleared predicate device, rather than requiring new clinical studies to establish performance against specific, pre-defined acceptance criteria for the new device itself.
The document states:
- Trade/Device Name: Soyee Portable X-Ray Unit Model SY-HF-110
- Regulation Number: 21 CFR 892.1720
- Regulation Name: Mobile x-ray system
- Regulatory Class: II
- Product Code: IZL
- Indications for Use: Portable and mobile general purpose diagnostic radiography in the field and clinic applications.
To answer your request, information on acceptance criteria and a study proving device performance would typically be found in the 510(k) submission document itself (which is not provided here), where the comparison to the predicate device is detailed. The provided letter is the FDA's decision based on that submission.
Without the actual 510(k) submission, it's impossible to fill in the requested table and details about the study.
§ 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.