(85 days)
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No
The document describes standard digital X-ray technology and image processing, but there is no mention of AI, ML, or related concepts.
No
The device is used for capturing and processing X-ray images for diagnostic purposes, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures." This clearly indicates its use in diagnostic activities.
No
The device description explicitly states it includes hardware components such as a digital detector, X-ray generator interface, hardware interface box (HB), and an image acquisition workstation (AWS) which contains a monitor, keyboard, mouse, and computer. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general radiographic images of human anatomy" and to "replace radiographic film/screen systems in all general-purpose diagnostic procedures". This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description details an X-ray capture system with a digital detector, generator interface, and workstation for image acquisition, processing, and display. This aligns with the components of a medical imaging system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with biological specimens or in vitro analysis.
Therefore, the Digital X-ray Capture Device Saturn 8000-GS Systems is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Saturn 8000-GS system generates digital X-ray images that can be used for general X-ray system except fluoroscopic, and mammographic applications. The Saturn 8000-GS system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 8000-GS is intended to be used in same clinical application as traditional film-screen based general radiography system.
The Digital X-ray Capture Device Saturn 8000-GS Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
Product codes
MQB
Device Description
The "Digital X-ray Capture Device (Saturn 8000-GS System)" (as Saturn 8000-GS System) is equipped with digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a flat panel detector. The input X-ray photons are absorbed in scintillator layer that creates a visible light photon, and then the photon is absorbed in TFT-array to create an electrical charge which is representation of the X-ray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure can be triggered by detector, which initiate the exposure signal to the generator; or the exposure signal is triggered by the generator itself and the detector is acted as bucky receptor. The connection between generator and detector is via the hardware interface box (HB), which can also connect the hand switch. The Saturn 8000-GS System contains the operation workstation software, which is installed on acquisition ("AWS"), which contains monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench testing and electrical safety further substantiate equivalence to the predicate. Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-3 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2007). All test results were satisfactory.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows a stylized logo with two letters. The first letter is a large, bold "N", and the second letter, to the right of the "N", is a smaller "M". The letters are in black and the background is white. The logo has a slightly distressed or textured appearance.
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| Doc. NO. | |
|---|---|
| Rev. NO. | 1.0 |
| Issued date | Page |
| 2011.01.12 | 15 of 75 |