(22 days)
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No
The description details a standard automatic film processor using chemical baths and mechanical transport, with no mention of AI or ML capabilities.
No
The device processes medical imaging films for viewing by physicians. It does not directly provide therapy or therapeutic benefit to a patient.
No
The device processes medical imaging films for viewing by physicians. It does not perform any diagnostic function itself, but rather prepares the images for a physician to interpret.
No
The device description clearly outlines multiple hardware components including chemical tanks, transport racks, a washer, a dryer, and mechanical transport mechanisms, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The described device is an automatic film processor. Its function is to chemically process exposed medical imaging films. It does not interact with or analyze biological specimens from the human body.
- Intended Use: The intended use is to process films for viewing by physicians, which is a step in the workflow of medical imaging, not a diagnostic test performed on a biological sample.
The device is a piece of equipment used in the processing of medical images, which are then interpreted by a physician. It does not perform any diagnostic analysis on a biological sample.
N/A
Intended Use / Indications for Use
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.
Product codes
90 IXW
Device Description
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,
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound, X-Ray, Nuclear Medicine, Computed Tomography, Mammography, Cardiology, and Magnetic Resonance
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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,
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.
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:
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.
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
OR
Over –the-Counter Use (Optional Format 1-2-96)