(19 days)
Not Found
No
The document describes "enhanced image processing" but does not mention AI, ML, or any related terms, nor does it describe any features or functionalities typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or analysis based on learned patterns). The description focuses on user interface improvements and standard image manipulation capabilities.
No
The device is used for diagnostic imaging, helping physicians with diagnosis rather than providing direct therapy.
No.
The device produces images that aid physicians in diagnosis, but it does not directly perform the diagnosis itself.
No
The device description clearly outlines hardware components like "imaging plate" and "digitizer," indicating it is a system that includes both hardware and software, not a software-only device.
Based on the provided text, 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 description clearly states that this device is a computed radiography imaging system. It processes X-ray images captured from the human body to aid in diagnosis. It does not analyze biological samples.
- Intended Use: The intended use is to "make them ready for interpretation by the physician" and "provide diagnostic quality images to aid the physician with diagnosis." This refers to the interpretation of medical images, not the analysis of biological samples.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Agfa's Computed Radiography Systems with NX1.0 workstations are intended for use in the identification, generation, acquisition, processing and filing of computed radiography images in order to make them ready for interpretation by the physician.
Agfa's Computed Radiography Systems with NX1.0 workstations are indicated to provide diagnostic quality images to aid the physician with diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
MOB, LLZ
Device Description
The predicate and newly modified devices are computed radiography imaging systems. Instead of traditional screens and photographic film for producing the diagnostic image, these systems system utilize an "imaging plate," a plate coated with photo-stimulable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. After exposure, this imaging plate is inserted into a digitizer that scans it with a laser and releases the latent image in the form of light that is converted into a digital image file. The image can then be previewed on a computer workstation, adjusted if necessary then stored locally, sent to an archive, printed or sent to a softcopy capable display such as a PACS system.
The NX1.0 and QS 3.0 (predicate) workstations are similar. The NX1.0 workstation includes a number of improvements including:
- . A more intuitive user interface.
- Enhanced image processing. .
- Easier installation and updates, .
- Enhanced image manipulation, display and export capabilities, .
The basic principles of operation are unchanged.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Radiography
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The computed radiography system with NX1.0 workstation has been tested for proper performance to specifications through various in-house reliability and imaging performance demonstration tests. The device also meets the requirements of EN 60601-1-1 and EN 60601-1-2.
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.
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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D. I of 2
Agfa Corporation Premarket Notification: Computed Radiography System with NX Workstation
510(k) Summary: Computed Radiography System with NX1.0 Workstation
Common/Classification Name: Computed Radiography, 21 CFR 892.1650
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Jeffery A. Jedlicka, Prepared: December 20, 2005
A. LEGALLY MARKETED PREDICATE DEVICES
This is a Special 510(k) for a device modification. The modified device is Agfa's Computed Radiography system with NX1.0 workstation.
The predicate device is Agfa's Computed Radiography System with QS 3.0 workstation which was introduced under a letter to file in March 2004. It's predecessor was the ADC QS/ID workstation was cleared by FDA on March 28,2001 (K010571).
DEVICE DESCRIPTION B.
The predicate and newly modified devices are computed radiography imaging systems. Instead of traditional screens and photographic film for producing the diagnostic image, these systems system utilize an "imaging plate," a plate coated with photo-stimulable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. After exposure, this imaging plate is inserted into a digitizer that scans it with a laser and releases the latent image in the form of light that is converted into a digital image file. The image can then be previewed on a computer workstation, adjusted if necessary then stored locally, sent to an archive, printed or sent to a softcopy capable display such as a PACS system.
The NX1.0 and QS 3.0 (predicate) workstations are similar. The NX1.0 workstation includes a number of improvements including:
- . A more intuitive user interface.
- Enhanced image processing. .
- Easier installation and updates, .
- Enhanced image manipulation, display and export capabilities, .
The basic principles of operation are unchanged.
INTENDED USE c.
Agfa's Computed Radiography Systems with NX1.0 workstations are intended for use in the identification, generation, acquisition, processing and filing of computed radiography images in order to make them ready for interpretation by the physician.
G-2
1
D. SUBSTANTIAL EQUIVALENCE SUMMARY
Agfa's Computed Radiography Systems with NX1.0 workstations have the same indications for use as the legally marketed predicate devices, so the first decision point in the 510(k) Decision Algorithm is straight-forward. They have the same technological characteristics as the predicate device. This premarket notification has described the characteristics of the devices in sufficient detail to assure substantial equivalence. For the few characteristics that may not be precise enough to ensure equivalence, performance data was collected, and this data demonstrates substantial equivalence. In keeping with the format of a Special 510(k) for Device Modification, performance data were not included in the submission, but the declarations in Exhibits I and H provide certification that the data demonstrate equivalence.
TECHNOLOGICAL CHARACTERISTICS ni
The technological characteristics are the same in the proposed and predicate devices.
F. TESTING
The computed radiography system with NX1.0 workstation has been tested for proper performance to specifications through various in-house reliability and imaging performance demonstration tests. The device also meets the requirements of EN 60601-1-1 and EN 60601-1-2.
G. CONCLUSIONS
This Special 510(k) for Device Modification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
p. 2 of 2
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of a human figure embracing a bird, which is a common symbol associated with health and human services.
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
Mr. Jeffery A. Jedlicka Senior Regulatory Affairs and Compliance Manager AGFA Corporation Healthcare 10 South Academy Street AUG 23 2013 GREENVILLE SC 29601
Re: K053634
Trade/Device Name: Computed Radiography System with NX1.0 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB and LLZ Dated: December 20, 2005 Received: December 29, 2005
Dear Mr. Jedlicka:
This letter corrects our substantially equivalent letter of January 17, 2006.
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, 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
Janine M. Morr Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K053634 510(k) Number (if known):
Device Name: Computed Radiography System with NX1.0 Workstation
Indications for Use:
Agfa's Computed Radiography Systems with NX1.0 workstations are indicated to provide diagnostic quality images to aid the physician with diagnosis.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
ANDIOR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Daniel A. Leyson
Division of Ronand and Radiological D 510(k) Numbe
K-2