To process (develop) medical imaging films for viewing by physicians. This may be used in the imaging modalities of Ultrasound, X-Ray, Nuclear Medicine, Computed Tomography, Mammography, Cardiology, and Magnetic Resonance.

Device Description

All currently marketed automatic film processors have the same basic components, including a feed and detection mechanism, a processing system consisting of chemical tanks and transport racks, a washer, a dryer, a receiving bin, and controls and indicators. Major subsystems include water supply, temperature regulation, chemical replenishment, and solution circulation.

The device performs standard photographic processing of previously exposed sheets or rolls of silver-halide based films. The processed films contain acquired anatomical images for viewing by physicians, typically of the radiological discipline specialty. The photographic processing (developing) technique employed by these automatic processors is the same as all devices manufactured by several companies, and has gone basically unchanged in approximately fifteen years. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then ejected for viewing and archival purposes.

The Agfa family of automatic film processors also offers additional features such as daylight handling and processing, laser film recorder docking, and automatic film handling for various types and sizes of imaging films used in the above radiographic applications. Some models offer the E.O.S. (Environmentally Optimized System) feature. This feature employs an additional fixer tank technique that reduces fixer solution consumption and waste.

AI/ML Overview

This document, K981280, is a 510(k) summary for Agfa's Automatic Film Processors. It states the intended use of the device and describes its basic components and function. However, it does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. This document serves as a regulatory submission confirming substantial equivalence to existing devices, not a performance study report.

Therefore, I cannot provide the requested information from the given text.

Summary

{0}------------------------------------------------

K981280

APR 3 0 1998

SECTION 1

510(k) SUMMARY

Agfa's Automatic Film Processor product family is designed for the intended use of processing standard medical x-ray, laser, and video types of imaging films. These would be used in all radiographic imaging modalities including but not limited to Ultrasound, X-Ray, Nuclear Medicine, Computed Tomography, Mammography, Cardiology, and Magnetic Resonance,

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present.

Image /page/1/Picture/1 description: The image shows a 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. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1998

Michael Sullivan AGA Division, Bayer Corporation Official Correspondent 100 Challenger Road Ridgefield Park, NJ 07660-2199

Re:

K981280 CP1000, Curix HT 330, Classic E.O.S., Curix HT 530, Mamoray HT 300 Dated: April 5, 1998 Received: April 8, 1998 Regulatory class: II 21 CFR 892.1900/Procode: 90 IXW

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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 (2) 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. Please note: 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.fda.gov/cdr/dsmaldsmam.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

SECTION 3 PRESCRIPTION DEVICE

Indications For Use:

K. O'Sullivan

Michael Sullivan Official Correspondent

Concurrence of CDRH, Office of Device Evaluation

Shirl A. Seigman

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981280

Prescription Use (Per 21 CFR 801.1090

Over –the-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 892.1900 Automatic radiographic film processor.

(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.