(97 days)
The AeroDR SYSTEM is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The AeroDR SYSTEM is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
The AeroDR SYSTEM is a digital imaging system to be used with diagnostic x-ray systems. It consists of AeroDR Detector (flat panel digital detector), Console CS-7 (operator console), AeroDR Interface Unit, AeroDR Generator Interface Unit, AeroDR Access Point and AeroDR Battery Charger. Images captured with the flat panel digital detector can be communicated to the operator console via wired connection or wireless, depend on user's choice.
The provided text describes a 510(k) summary for the Konica Minolta AeroDR SYSTEM. However, it does not contain information about acceptance criteria for device performance or any studies conducted to prove it meets such criteria.
The document mainly focuses on:
- Company and Device Identification: Basic information about the manufacturer and the device.
- Device Description: General overview of the AeroDR SYSTEM components and its function as a digital imaging system.
- Indications for Use: Specifies what the device is intended for and what it is not for (general radiography, not mammography, fluoroscopy, etc.).
- Substantial Equivalence: Claims that the device is substantially equivalent to predicate devices (Carestream DRX-1 System, K090318 and KONICAMINOLTA, FlexDR C30, K082347) based on similar indications for use, detector type (FPD with CsI scintillator), principles of operation, and technological characteristics.
- Safety Information: Mentions compliance with IEC 60601-1 and IEC 60601-1-2 standards and risk analysis conducted per ISO 14971.
- Conclusion: Reaffirms substantial equivalence to predicate devices.
- FDA Correspondence: An FDA letter confirming the 510(k) clearance and reiterating general regulatory requirements.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies based on the provided text. The document describes a substantial equivalence submission, which typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance study data against specific acceptance criteria.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.