(55 days)
The IntraX Film Processor is an Automatic film processor used by dental offices to develop x-ray films. all sizes of intra - oral film .
IntraX Film Processor
Trade Name: IntraX Film Processor
Common Name: Automatic Film processor
Classification name: Processor, Radiographic-Film, Automatic
Device Class 2
Regulation Number: 892.1900
This is a 510(k) summary for a radiographic film processor, not an AI/ML medical device. Therefore, the information typically requested in questions 1 through 9 (related to acceptance criteria, study design, ground truth, and human-in-the-loop performance for AI/ML devices) is not applicable or present in this document.
The document describes a traditional medical device (IntraX Film Processor) and its substantial equivalence to predicate devices, focusing on regulatory classification, indications for use, and general controls provisions of the FDA. It does not contain information about AI/ML algorithm performance, test sets, training sets, or expert adjudication that would be used to assess an AI/ML-driven device.
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Image /page/0/Picture/0 description: The image shows a handwritten number, "K093503", in black ink on a white background. The number is written in a simple, legible style. There is a black blotch in the upper right corner of the image, partially obscuring the background. The number appears to be a code or identifier, possibly for a document or item.
JAN - 6 2010
Image /page/0/Picture/2 description: The image shows the logo for VELOPEX INTERNATIONAL. The word "VELOPEX" is in large, bold letters at the top of the image. Below that, the word "INTERNATIONAL" is in smaller, bold letters. The logo is black and white.
105 East 17th Street St. Cloud, FL 34769 1-888-835-6739
Date: November 12, 2009
510(k) Holder: Velopex International Inc Device Name: IntraX Film Processor Contact: Anthony Urella Phone: 407-957-3900 Fax: 407-957-3927 Email: tony@velopexusa.com
510 (k) Summary
Device Name:
IntraX Film Processor
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Trade Name: IntraX Film Processor
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Common Name: Automatic Film processor
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Classification name: Processor, Radiographic-Film, Automatic
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Device Class 2
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Regulation Number: 892.1900
Legally marketed device to which we are claiming equivalence:
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Air Techniques Inc. (Registered Establishment # 2428225) Peri-Pro Film Processor
- Air Techniques Inc. (Registered Establishment # 2428225) A A/T 2000 Automatic Film Processor
- Dent-X Co., Model 410 Dental X-Ray Film Processor #K874118 A
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
Mr. Anthony Urella Vice President, Sales & Marketing Velopex International, Inc. 105 E. 17th Street SAINT CLOUD FL 34769
JAN - 6 2010
Re: K093503
Trade/Device Name: IntraX Film Processor Regulation Number: 21 CFR 892.1900 Regulation Name: Automatic radiographic film processor Regulatory Class: II Product Code: IXW Dated: November 12, 2009 Received: November 12, 2009
Dear Mr. Urella:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): K093503
Intra X Film Processor Device Name:
Indications for Use:
The IntraX Film Processor is an Quitimatic Tim processor used by dental offices to develop x-ray films. all sizes of intra - oral film .
Over-The-Counter Use Prescription Use > (21 CFR 801 Subpart C) . (Part 21 CFR 801 Subpart D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
Page 1 of 1
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.