(284 days)
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No
The document describes standard digital radiography technology and image processing features common to such systems, with no mention of AI, ML, or related concepts.
No.
The device is used to take diagnostic radiographic exposures and provide high-resolution radiographic images, which are used for diagnosis rather than therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device permits a qualified/trained doctor or technologist to take "diagnostic radiographic exposures," and the "Mentions image processing" section notes that image processing enables the operator to view "diagnostic details." This indicates the device is used for diagnostic purposes.
No
The device description explicitly mentions a "single CCD detector," which is a hardware component used for image capture. This indicates the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is integrated into a stationary radiography system for taking diagnostic radiographic exposures of various body parts. This is a medical imaging device used for diagnosis based on anatomical structure, not on the analysis of biological samples.
- Device Description: The description focuses on the technical aspects of capturing digital radiographic images using a CCD detector.
- Input Imaging Modality: The input modality is radiographic, which is a form of medical imaging, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the Atlas is a component of a medical imaging system used for diagnostic radiography, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The ATLAS is integrated into the user`s stationary radiography system. This typical configuration permits a qualified/trained doctor or technicolgosist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient. Applications can be performed with patient sitting, standing of lying in the prone or supine positions in an integrated system. The ATLAS is not intended for mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The Atlas is provided high resolution radiographic images in a digital format without use of film , chemistry, cassettes or expensive imaging plates. With 98% of fill factor in each pixel, there is a maximum efficiency and lower dose required for image capture. It has single CCD detector.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest abdomen, extremities, and other body parts
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified/trained doctor or technologist
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of ATLAS is as safe and effective as the predicate devices, has few technological differences, but there are no new indications for use and without raising any new safety and/or effectiveness concerns.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
510(K) SUMMARY
[as required by 807.92(c)]
DEC 2 1 2010
A. 510k Number:
B. Applicant:
Company name: PATS CORP Address: 49 Candlewood Way, Buena Park, CA 90621, USA Contact person: Mr Brandon Choi Phone: 714-523-1592 Fax: 714-523-1592
C. Proprietary and Established Names: COMED CO LTD Address: #58, Hakdong-Ri, Chowol-Eup, Gwangju-City, Gyeonggi-Do, Korea
D. Requlatory Information
Classification : Class II CFRcord : 892 . 1680 , Regular Name : Stationary X-ray system Product cord : MQB
E. Intended Use
The ATLAS is integrated into the user`s stationary radiography system. This typical configuration permits a qualified/trained doctor or technicolgosist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient. Applications can be performed with patient sitting, standing of lying in the prone or supine positions in an integrated system. The ATLAS is not intended for mammography.
F. Device Description
The Atlas is provided high resolution radiographic images in a digital format without use of film , chemistry, cassettes or expensive imaging plates. With 98% of fill factor in each pixel, there is a maximum efficiency and lower dose required for image capture. It has single CCD detector.
For the technological characteristics the Company is relying on the above mentioned
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1
ATLAS. COMED Co., Ltd. believes that ATLAS is substantially equivalent in intended use, principles of operation, and technological characteristics to the predicate devices presented above and any differences with Xaminer (K061595), QXR-9 (K073056) do not raise new types of safety or effectiveness issues, as further discussed below.
| Model Name | ATLAS | Xaminer | QXR-9 |
|---|---|---|---|
| 510K Number | Not yet | K061595 | K073056 |
| Classification | Class II Device / | ||
| MQB (21 CFR 892.1650) | Class II Device / | ||
| MQB (21 CFR 892.1650) | Class II Device / | ||
| MQB (21 CFR 892.1650) | |||
| INTENDED USE | The ATLAS is integrated into the user's | ||
| stationary radiography system. | |||
| This typical configuration permits a | |||
| qualified/trained doctor or technologist | |||
| to take a range of head-to-toe diagnostic | |||
| radiographic exposures of the skull, | |||
| spinal column, chest abdomen, extremities, | |||
| and other body parts on both | |||
| adult and pediatric patients. Applications can | |||
| be performed with patient. Applications can be | |||
| performed with patient sitting standing of | |||
| lying in the prone or supine positions in an | |||
| intergrated system | |||
| The ATLAS is not intended for mammography | The Xaminer (510k submission device) is | ||
| integrated into the user's stationary radiography | |||
| system This typical configuration permits a | |||
| qualified/trained doctor or technologist to take a | |||
| range of head-to-toe diagnostic radiographic | |||
| exposures of the skull spinal column, chest | |||
| abdomen, extremities, and other body parts on | |||
| both adult and pediatric patients. Applications | |||
| can be performed with patient sitting, standing or | |||
| lying in the prone or supine positions in an | |||
| integrated system | |||
| The Xaminer (510k submission device) is not | |||
| intended for mammography | QXR-9 Digital Radiography system is | ||
| indicated for digital imaging solution | |||
| designed for general radiographic system for | |||
| human anatomy. It is intended to replace film | |||
| or screen based radiographic systems in all | |||
| general purpose diagnostic procedures. Not | |||
| to be used for mammography. | |||
| Feature | The Atlas is provided high resolution | ||
| radiographic images in a digital format without | |||
| use of film, chemistry, cassettes or expensive | |||
| imaging plates. With 98% of fill factor in each | |||
| pixel there is a maximum efficiency and lower | |||
| dose required for image capture. It has single | |||
| CCD detector | The Xaminer is the latest version of Xplorer | ||
| digital radiographic detectors. It includes | |||
| features and functions that have been developed | |||
| since the introduction of the original Xplorer | |||
| 1000 (predicate device). Xaminer provides high | |||
| resolution radiographic images at 3.2 lp/mm | |||
| in a digital format without use of film, chemistry, | |||
| cassettes or expensive imaging plates. With 98 % | |||
| of fill factor in each pixel there is a maximum | |||
| efficiency and lower dose required for image | |||
| capture. It has single CCD detector with 9 mega | |||
| pixel digitized at 14 bits per pixels | The QXR-9 Digital Radiography Systems is a | ||
| high-resolution digital imaging system | |||
| designed for digital radiography. It is | |||
| designed to replace conventional film | |||
| radiography techniques. This system consists | |||
| of Detector Power Supply Unit, Accessories, | |||
| and S/W. The S/W is operated at a | |||
| workstation that is using Windows XP based | |||
| OS as its operating system. The system allows | |||
| the operator to acquire and display | |||
| images(Image size 3072x3072 pixels) or | |||
| 1600 x 1200 high resolution monitor. | |||
| Various features of S/W such as image | |||
| inversion, image processing, zooming, | |||
| panning, window level adjustment, contrast | |||
| adjustment etc enable the operator to view | |||
| diagnostic details difficult to see using | |||
| conventional non-digital techniques. | |||
| STANDARD | EN ISO 14971 | ||
| EN 60601-1 | |||
| EN 60601-1-4 | |||
| EN 60601-1-2 | EN ISO 14971 | ||
| EN 60601-1 | |||
| EN 60601-1-4 | |||
| EN 60601-1-2 | EN ISO 14971 | ||
| EN 60601-1 | |||
| EN 60601-1-2 | |||
| Sensor | CCD+ scintillator | CCD- scintillator | CCD- scintillator |
| Imaging Pixels | 3,103 x 3,085(9 Megapixel) | 3,072 x 3,072 (9 Megapixel) | 3,072 x 3,072 (9 Megapixel) |
Comparison with predicate 2.
2
| Active Image Size | 17" x 17" | 43 cm x 43 cm (17" x 17") | 43 cm x 43 cm (17" x 17") |
|---|---|---|---|
| Pixel Size | 144 microns | 144 microns | 144 microns |
| Nyquist Resolution | 3.5 lp/mm | 3.2 lp/mm | 3.5 lp/mm |
| Bit Depth | 16Bit capture | 14 bit capture | 14 bit capture |
| Fill Factor | 98% | 100% |