(30 days)
Not Found
No
The description focuses on the hardware and basic digital image conversion process of a computed radiography system. There is no mention of AI, ML, or advanced image processing techniques that would typically involve these technologies.
No
The device is indicated for use to provide diagnostic quality images, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" 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 "digitizer," and a "computer workstation," indicating it is a physical system, not software-only.
Based on the provided text, the CR30-X is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the CR30-X is used to "provide diagnostic quality images to aid in physician diagnosis" from X-ray imaging. This is related to in vivo imaging (imaging within a living organism), not in vitro testing (testing outside of a living organism, typically on biological samples).
- Device Description: The description details a system that processes X-ray images captured from a patient. It involves imaging plates, digitizers, and workstations for viewing and processing these images. This aligns with medical imaging devices used for diagnosis based on anatomical structures, not laboratory tests on biological specimens.
- Input Imaging Modality: The input modality is X-ray, which is an in vivo imaging technique.
- Anatomical Site: The specified anatomical sites (chest, skeletal, gastro-intestinal) are all parts of the human body, further indicating an in vivo application.
IVD devices are typically used to examine specimens such as blood, urine, tissue, etc., to detect diseases, conditions, or infections. The CR30-X's function is to capture and process images of the internal structures of a patient's body.
N/A
Intended Use / Indications for Use
The CR30-X is used to scan exposed X-ray cassettes, containing an erasable image plate (IP). This device is part of a system, consisting of X-ray cassettes with erasable phosphor image plates, an identification for the cassettes and a workstation where the resulting digital image information is further processed and routed. It is intended that this device is only operated in a radiological environment by qualified personnel.
The CR30-X is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR30-X is intended to be used mainly in chest, skeletal and gastro-intestinal x-ray imaging applications.
Product codes
MQB
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 utilize an "imaging plate," a plate coated with photo-stimulatable 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 CR30-X and the CR25.0 are similar. The CR30-X utilizes an improved light collector to obtain maximum light efficiency. However, the basic principles of operation are unchanged.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
chest, skeletal and gastro-intestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiological environment by qualified personnel.
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 CR30-X 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)
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.
0
Agfa Corporation Premarket Notification: CR30-X
Ko62223
510(k) Summary CR3
Common/Classification Name: Computed Radiography, 21 CFR 892.1630
Agfa Corporation 10 South Academy Street Greenville, SC 29601
SEP - 1 2006
Contact: Patrick Lynch, Prepared: July 24, 2006
LEGALLY MARKETED PREDICATE DEVICES A.
This is a Special 510(k) for a device modification. The modified device is Agfa's CR30-X.
The predicate device is Agfa's CR25.0 which was cleared by FDA on July 22, 2004 (K041701).
DEVICE DESCRIPTION 8.
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 utilize an "imaging plate," a plate coated with photo-stimulatable 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 CR30-X and the CR25.0 are similar. The CR30-X utilizes an improved light collector to obtain maximum light efficiency. However, the basic principles of operation are unchanged.
். INTENDED USE
The CR30-X is used to scan exposed X-ray cassettes, containing an erasable image plate (IP). This device is part of a system, consisting of X-ray cassettes with erasable phosphor image plates, an identification for the cassettes and a workstation where the resulting digital image information is further processed and routed. It is intended that this device is only operated in a radiological environment by qualified personnel.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
Agfa's CR30-X has the same indications for use and 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
1
Agfa Corporation Premarket Notification: CR30-X
declarations provide certification that the data demonstrate equivalence.
TECHNOLOGICAL CHARACTERISTICS ய்
The technological characteristics are the same in the proposed and predicate devices.
F. TESTING
f
The CR30-X 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.
ુ. CONCLUSIONS
This Special 510(k) for Device Modification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Trug 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 shows the logo for the Department of Health and Human Services. The logo includes the department's name in blue, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written in a clear, sans-serif font. To the left of the text is a graphic element, also in blue, that appears to be a stylized representation of the human form.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Patrick J. Lynch Manager of Regulatory Affairs AGFA Corporation Healthcare 10 S. Academy Street P.O. Box 19048 GREENVILLE SC 29602-9048
AUG 2 3 2013
Re: K062223
Trade/Device Name: Agfa CR30-X Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 24, 2006 Received: August 2, 2006
Dear Mr. Lynch:
This letter corrects our substantially equivalent letter of September 1, 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
3
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. 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):
Device Name: Agfa CR30-X
Indications for Use:
The CR30-X is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR30-X is intended to be used mainly in chest, skeletal and gastro-intestinal x-ray imaging applications.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation {ODE)
David R. Ingram
(Division Sign-Off) Division of Reproductive, and Radiological Devic 510(k) Number
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