(305 days)
The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.
The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.
I am sorry, but the provided text from the FDA 510(k) summary for the SOPIX device does not contain information about acceptance criteria, device performance metrics, study design (sample sizes, data provenance, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies (MRMC or standalone).
This document is primarily a letter from the FDA confirming the substantial equivalence of the SOPIX device to existing legally marketed devices, along with the device's indications for use. It details regulatory information rather than a performance study.
Therefore, I cannot provide the requested table and study details based on the input text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2015
SOPRO - Acteon Group % Mr. Rick Rosati Quality Manager Satelec Acteon Group 124 Gaither Drive. Suite 140 MOUNT LAUREL NJ 08054
Re: K142995
Trade/Device Name: SOPIX Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: July 28, 2015 Received: July 28, 2015
Dear Mr. Rosati:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142995
Device Name SOPIX
Indications for Use (Describe)
The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.