ADC COMPACT (AGFA DIAGNOSTIC CENTER)

K974597 · Bayer Corp., Agfa Div. · KPR · Mar 9, 1998 · Radiology

Device Facts

• Record ID: K974597
• Device Name: ADC COMPACT (AGFA DIAGNOSTIC CENTER)
• Applicant: Bayer Corp., Agfa Div.
• Product Code: KPR · Radiology
• Decision Date: Mar 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended 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.

Device Story

ADC COMPACT is a computed radiography (CR) imaging system replacing conventional X-ray film cassettes. It utilizes imaging plates coated with photo-stimulatable storage phosphors to capture latent X-ray images. The system scans these plates, releasing the latent image as light, which is converted into a digital bit stream. This digital data is stored and transmitted to a PACS network in DICOM format. Used in clinical settings, the device is operated by radiology staff to produce diagnostic images for physician review. The system facilitates filmless radiography, enabling digital archiving and electronic distribution of diagnostic images to support clinical decision-making.

Clinical Evidence

Clinical environment testing was conducted to assess safety and effectiveness. No specific performance metrics (e.g., sensitivity, specificity) were provided in the summary.

Technological Characteristics

Computed radiography system using photo-stimulatable storage phosphor imaging plates. Converts X-ray energy to digital bit stream. Connectivity via DICOM format to PACS. Software risk evaluated per IEC 601-1-4, classified as Lower Level of Concern.

Indications for Use

Indicated for patients requiring diagnostic X-ray imaging, specifically for chest, skeletal, and gastrointestinal applications, to aid in physician diagnosis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ADC 70 (K904519A)

Submission Summary (Full Text)

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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

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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:

K974597

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## 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.