(24 days)
Not Found
Not Found
No
The description focuses on the mechanical process of developing, fixing, washing, and drying x-ray film, with no mention of AI or ML for image analysis or other functions.
No
The device is an automatic x-ray film processor used to develop, fix, wash, and dry medical x-ray film, which is a processing step, not a therapeutic intervention.
No
This device processes x-ray film; it does not diagnose medical conditions.
No
The device is described as an "automatic x-ray film processor," which is a physical piece of equipment used to process x-ray film. This description clearly indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device's intended use is to process medical x-ray film. This is a process that prepares the film for visual interpretation by a medical practitioner. It does not involve testing samples taken from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Device Description: It's described as an "automatic x-ray film processor," which aligns with its intended use of processing film, not analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on the analysis of those samples.
- Using reagents or assays.
Therefore, the All-Pro 100 Plus and All-Pro 200 are devices used in the process of generating medical images, but they are not IVDs.
N/A
Intended Use / Indications for Use
The All-Pro 100 Plus and All-Pro 200 are automatic x-ray film processors. They develop, fix, wash and dry medical x-ray film. Properly processed x-ray films are available for reading by medical practitioners more rapidly and with more consistency than with manual processing.
Product codes
90 IXW
Device Description
The All-Pro 100 Plus and All-Pro 200 are automatic x-ray film processors. They develop, fix, wash and dry medical x-ray film.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical practitioners
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)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1599
Frederick R. Fisher Vice President All Pro Imaging Corporation 70 Cantiague Rock Road P.O. Box 870 Hicksvile, New York 11801
RE:
K991435 All-Pro Plus & All Pro 200 Dated: April 23, 1999 Received: April 26, 1999 Regulatory Class: II 21 CFR 892.1900/Procode: 90 IXW
Dear Mr. Fisher:
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 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 redassified 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 Federal Requilations, 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 (QS) 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 requlatory 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting 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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Image /page/1/Picture/0 description: The image shows a logo with the text "All-Pro" in a stylized font. The text is white and bold, set against a background of black vertical stripes. The stripes vary in width and spacing, creating a barcode-like effect. The overall design is simple and high-contrast, making the text stand out.
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510(k) Number: K_99/435
All-Pro 100 Plus and All-Pro 200 Device Name:
Indications for Use:
The All-Pro 100 Plus and All-Pro 200 are automatic x-ray film processors. They develop, fix, wash and dry medical x-ray film. Properly processed x-ray films are available for reading by medical practitioners more rapidly and with more consistency than with manual processing.
Daniel A. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D vices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)