(90 days)
K904519A
K904519A
No
The description focuses on the physical components and process of converting X-ray energy into a digital image using phosphors and scanning, with no mention of AI or ML for image processing or analysis.
No
The device is used for diagnostic imaging, specifically X-ray imaging, to aid in physician diagnosis, not for treating diseases or conditions.
Yes
The device is used to "provide diagnostic quality images for aid in physician diagnosis," explicitly stating its role in diagnostic processes.
No
The device description clearly outlines hardware components like imaging plates, a scanning device, and a system that converts light to a digital bit stream, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the ADC COMPACT clearly states it is an X-Ray imaging system that replaces conventional X-Ray cassettes and utilizes imaging plates to capture latent images from X-Ray energy. It processes these images for physician diagnosis.
- The intended use is for providing diagnostic quality images for aid in physician diagnosis. This aligns with the function of medical imaging devices, not devices that analyze biological samples.
- The device description focuses on the imaging process and the technology used to capture and digitize X-Ray images. There is no mention of analyzing blood, urine, tissue, or any other bodily fluid or substance.
Therefore, the ADC COMPACT is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To provide diagnostic quality images for aid in physician diagnosis. This is used in the X-Ray imaging modality, mainly in Chest, Skeleton, and Gastro-Intestinal imaging applications.
Product codes
90 KPR
Device Description
The ADC COMPACT is a Computed Radiography Imaging System. This system replaces conventional X-Ray cassettes that contain one or two intensifying screens and photographic light sensitive film. Computed radiography utilizes filmless cassettes. Instead of screens and photographic film to obtain the diagnostic image, the system employs what is termed as an imaging plate. This plate is coated with photo stimulatable storage phosphors that are sensitive to the X-Ray energy, and capable of retaining a latent image. This imaging plate is inserted into a device that scans it and releases the latent image in the form of light which is converted into a digital bit stream. This bit stream of image data is stored, and introduced to the PACS (Picture Archiving and Computerized System) network in DICOM format.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Chest, Skeleton, and Gastro-Intestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
AGFA has conducted adequate safety and effectiveness testing in clinical environments that would be relevant to an assessment of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K904519A
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
MAR 1 0 1998
1. 510(k) SUMMARY
The ADC COMPACT is a Computed Radiography Imaging System. This system replaces conventional X-Ray cassettes that contain one or two intensifying screens and photographic light sensitive film. Computed radiography utilizes filmless cassettes. Instead of screens and photographic film to obtain the diagnostic image, the system employs what is termed as an imaging plate. This plate is coated with photo stimulatable storage phosphors that are sensitive to the X-Ray energy, and capable of retaining a latent image. This imaging plate is inserted into a device that scans it and releases the latent image in the form of light which is converted into a digital bit stream. This bit stream of image data is stored, and introduced to the PACS (Picture Archiving and Computerized System) network in DICOM format.
The major difference between the ADC COMPACT and the previous model in commercial distribution is the actual physical size of the portion of the system that reads and digitizes the imaging plates.
The ADC COMPACT is substantially equivalent to the previous model produced by AGFA, the proprietary name being the ADC 70 (K904519A). It is also substantially equivalent to other computed radiography systems produced by other manufacturers and currently in commercial distribution. AGFA has conducted adequate safety and effectiveness testing in clinical environments that would be relevant to an assessment of substantial equivalence.
System labeling has been conducted in a fashion consistent with the applicable sections of the Code of Federal Regulations (CFR 21).
The software employed by the ADC COMPACT has been evaluated and verified with respect to level of concern utilizing the methods suggested by the Office of Device Evaluation (ODE). The method of risk estimation used was the likelihood and severity model as adapted from the IEC 601-1-4 Standard. The result is that the software risk falls clearly into the Broadly Acceptable, or Lower Level of Concern range.
AGFA Agfa
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 1998
Michael Sullivan Official Correspondent Bayer Corporation, AGFA Division 100 Challenger Rd. Ridgefield Park, NJ 07660
Re:
ADC Compact Computed Radiography System Dated: December 8, 1997 Received: December 9, 1997 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR
Dear Mr. Sullivan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.ida.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
William Yu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) NUMBER:
DEVICE NAME:
Indications For Use:
To provide diagnostic quality images for aid in physician diagnosis. This is used in the X-Ray imaging modality, mainly in Chest, Skeleton, and Gastro-Intestinal imaging applications.
R. Ylennow
"11/10/87
Michael Sullivan Official Correspondent
Concurrence of CDRH, Office of Device Evaluation
Tamil C. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974597
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use (Optional Format 1-2-96)
Image /page/2/Picture/13 description: The image shows the word "AGFA" in bold, sans-serif font, followed by a black diamond shape. Inside the diamond, the word "Agfa" is written in a smaller, italicized font. The logo is simple and recognizable, with the bold "AGFA" text providing a strong visual anchor.