(132 days)
Not Found
No
The summary describes a digital X-ray detector and its image capture and display capabilities, but there is no mention of AI or ML being used for image processing, analysis, or any other function. The performance studies focus on standard imaging metrics and clinical equivalence to a predicate device.
No
The device is used for capturing radiographic images for diagnostic purposes, not for treating or preventing disease.
Yes
The device is described as capturing radiographic images for general-purpose diagnostic procedures, and images are reviewed by radiologists or physicians for diagnostic quality.
No
The device description explicitly states it is a "flat-panel type digital X-ray detector" and uses a "Detector Panel" to capture images, indicating it is a hardware device with associated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ATAL 8 and ATAL 8c are described as digital X-ray detectors used to capture radiographic images of human anatomy. This is an in vivo imaging process, meaning it involves imaging the body directly, not analyzing samples taken from the body.
- Intended Use: The intended use clearly states "general radiographic images of human anatomy," which aligns with in vivo imaging.
- Device Description: The description focuses on the technology of capturing X-ray images electronically, replacing traditional film/screen systems. This is consistent with an imaging device, not a diagnostic test performed on a sample.
Therefore, the ATAL 8 and ATAL 8c fall under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ATAL 8 and ATAL 8c are 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 (comma separated list FDA assigned to the subject device)
MQI, MOB
Device Description
The ATAL 8 and ATAL 8C are flat-panel type digital X-ray detectors that capture radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The ATAL 8 and ATAL 8C device differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector Panel is used to capture the image in electronic form. Once the system captures a radiographic image and subsequently displays and stores an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a workstation. The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network. The ATAL 8 and ATAL 8C differ only in the enclosure type. They have identical technological characteristics.
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
radiologists or physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical image sets were obtained for both the ATAL 8 and the predicate device and they were compared to show equivalence. The clinical evaluation was performed in accordance with the FDA Guidance Document wherein 30 pairs of clinical images are acquired and a board certified Radiologist reviewed the images and declared the new panel to be equivalent or better than the predicate device, and that the images are of diagnostic quality.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing included performance tests, EMC tests, Electrical Safety and software validation tests. The performance testing was based on the requirements of the FDA Guidance Document for Solid State Imaging Devices and included tests for MTF, DQE, Quantum Limited Performance, Effects of Aliasing, Output Signal Level and Linearity, and Lag or residual signal level from prior exposure.
Clinical image sets were obtained for both the ATAL 8 and the predicate device and they were compared to show equivalence. The clinical evaluation was performed in accordance with the FDA Guidance Document wherein 30 pairs of clinical images are acquired and a board certified Radiologist reviewed the images and declared the new panel to be equivalent or better than the predicate device, and that the images are of diagnostic quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
DRTech FLAATZ 750 K080064
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.
Not Found
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).
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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MAY – 3 2012
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| 510(k) Summary K113812 | |||
|---|---|---|---|
| Date prepared: | May 1, 2012 | ||
| Applicant: | Atlaim Corp. | ||
| 1018/19 Sicox Tower, Sangdaewon, Seongnam | |||
| Gyeonggi, 462-120 Korea | |||
| Contact person: | John Ross, General Manager, 949-929-5910 | ||
| Trade name: | ATAL 8 and ATAL 8 C | ||
| Common name: | Solid state X-ray imager | Class: | 2 |
| Classification name: | Solid state x-ray imager (flat panel/digital | ||
| imager) | Product code: | MQI | |
| Predicate device: | DRTech FLAATZ 750 K080064 | ||
| Device description: | The ATAL 8 and ATAL 8C are flat-panel type digital X-ray detectors that | ||
| capture radiographic images in digital format within seconds, eliminating | |||
| the need for an entire X-ray film or an image plate as an image capture | |||
| medium. The ATAL 8 and ATAL 8C device differs from traditional X-ray | |||
| systems in that, instead of exposing a film and chemically processing it to | |||
| create a hard copy image, a device called a Detector Panel is used to | |||
| capture the image in electronic form. Once the system captures a | |||
| radiographic image and subsequently displays and stores an image, | |||
| radiologists or physicians can adjust the image electronically to optimize | |||
| the view of the desired anatomy at a workstation. The system enables a | |||
| user to duplicate images without having to take additional exposures so | |||
| that the user can easily transmit a duplicate to the second physician who | |||
| needs the duplicate image through the network. The ATAL 8 and ATAL 8C | |||
| differ only in the enclosure type. They have identical technological | |||
| characteristics. | |||
| Intended use: | The ATAL 8 and ATAL 8C are 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. | |||
| Technological | |||
| characteristics: | Amorphous silicon detector producing an image of 3072x3072 pixels. The | ||
| image area is 430x430 mm with a resolution of 3.1 lp/mm. The intended | |||
| application of this detector is general radiography. | |||
| Non-clinical tests | |||
| submitted or relied upon: | Non-clinical testing included performance tests, EMC tests, Electrical | ||
| Safety and software validation tests. The performance testing was based | |||
| on the requirements of the FDA Guidance Document for Solid State | |||
| Imaging Devices and included tests for MTF, DQE, Quantum Limited | |||
| Performance, Effects of Aliasing, Output Signal Level and Linearity, and | |||
| Lag or residual signal level from prior exposure | |||
| Clinical tests submitted or | |||
| relied upon: | Clinical image sets were obtained for both the ATAL 8 and the predicate | ||
| device and they were compared to show equivalence. The clinical | |||
| evaluation was performed in accordance with the FDA Guidance Document | |||
| wherein 30 pairs of clinical images are acquired and a board certified | |||
| Radiologist reviewed the images and declared the new panel to be | |||
| equivalent or better than the predicate device, and that the images are of | |||
| diagnostic quality. | |||
| Substantial equivalence | |||
| conclusion: | The ATAL 8 and ATAL 8C and its predicate are different in minor details, | ||
| but they are substantially equivalent with respect to intended use, | |||
| technological and performance characteristics. The devices are as safe, as | |||
| effective, and perform as well as or better than the legally marketed | |||
| predicate device. |
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three curved lines, which are meant to represent the department's mission of promoting health and well-being. The seal is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MAY - 3 2012
Atlaim % Daniel Kamm, P.e. Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K113812
Trade/Device Name: ATAL 8 and ATAL 8c Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 22, 2012 Received: March 26, 2012
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, 1 Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K113812_
Device Name: ATAL 8 and ATAL 8c
Indications For Use:
The ATAL 8 and ATAL 8c 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.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K Kil3812
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