(21 days)
Not Found
No
The description focuses on the hardware and basic digital conversion process of a computed radiology system, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an imaging system used to produce diagnostic quality images, not to provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated for use to provide diagnostic quality images to aid in physician diagnosis."
No
The device description clearly outlines hardware components like an "imaging plate," a "device that scans it with a laser," and a system that converts light into a "digital bit stream." This indicates it is a hardware-based system, not software-only.
Based on the provided information, the CR50.0 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- CR50.0 Function: The CR50.0 is an X-ray imaging system. It captures images of the inside of the body using X-rays. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it provides "diagnostic quality images to aid in physician diagnosis" for chest, skeletal, and gastro-intestinal applications. This is consistent with medical imaging, not IVD testing.
Therefore, the CR50.0 falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CR50.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR50.0 is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.
Product codes
MOB
Device Description
The CR50.0, the predicate device, is a computed radiology imaging system. Instead of screens and photographic film for producing the diagnostic image, the CR50.0 system utilizes an "imaging plate," a plate coated with photo-stimulable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plate is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally, printed or sent to a Picture Archiving and Communications System (PACS) in DICOM format.
The CR50.0 is very similar to the CR25.0. It has a new scanning system that improves scan time and an image plate with an improved phosphor. However, the basic principles of operation are unchanged.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray
Anatomical Site
chest, skeletal, and gastro-intestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician diagnosis
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
The CR50.0 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
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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/1 description: The image shows a series of alphanumeric characters in a bold, sans-serif font. The characters appear to be "K050810", with some slight variations in the thickness of the strokes. The overall impression is that of a label or identifier, possibly from a document or product.
510(k) Summary CR50.0
Common/Classification Name: Computed Radiography, 21 CFR 892.1650
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Jeffery A. Jedlicka, Prepared: March 30, 2005
A. LEGALLY MARKETED PREDICATE DEVICES
This is a Special 510(k) for Device Modification. The predicate device is the device that was modified to produce the CR50.0, namely the CR25.0, which was cleared by FDA on 22 July 2004 as K041701.
DEVICE DESCRIPTION B.
Agfa Corporation
The CR50.0, the predicate device, is a computed radiology imaging system. Instead of screens and photographic film for producing the diagnostic image, the CR50.0 system utilizes an "imaging plate," a plate coated with photo-stimulable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plate is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally, printed or sent to a Picture Archiving and Communications System (PACS) in DICOM format.
The CR50.0 is very similar to the CR25.0. It has a new scanning system that improves scan time and an image plate with an improved phosphor. However, the basic principles of operation are unchanged.
C. INTENDED USE
The CR50.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR50.0 is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The CR50.0 has the same indications for use as the legally marketed predicate device, so the first decision point in the 510(k) Decision Algorithm is straight-forward. The CR50.0 has the same technological characteristics as the predicate device. This premarket notification has described the characteristics of the CR50.0 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 Section E provide certification that the data demonstrate equivalence.
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TECHNOLOGICAL CHARACTERISTICS ய்
The technological characteristics are the same in the proposed and predicate devices.
F. TESTING
The CR50.0 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.
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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
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. Jeffrey A. Jedlicka Manager of Regulatory Affairs AGFA Corporation Healthcare 10 South Academy Street GREENVILLE SC 29601
AUG 23 2013
Re: K050810
Trade/Device Name: CR50.0 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 30, 2005 Received: March 31, 2005
Dear Mr. Jedlicka:
This letter corrects our substantially equivalent letter of April 21, 2005.
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
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
510(k) Number (if known): K 0508 10
Device Name: CR50.0
Indications for Use:
The CR50.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR50.0-is intended to be used mainly in chest, skeletal and gastro-intestinal imaging applications.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
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)
Vancy C. Bardon
{Division Sian-Off}/ Division of Reproductive, Abdominal and Radiological Devices 510(k) Number