(109 days)
Scannerside Dose check is intended for providing Computed Tomographic (CT) Dose Check feature to CT X-ray systems. The Scannerside Dose Check is specifically indicated for providing the Computed Tomography Dose Check feature with notifies and alerts the CT equipment operators, prior to a scan, if the estimated dose is above a predefined threshold. This device is intended for CT scanners not equipped with this functionality. The device is indicated for use by professional personnel.
Not Found
This document is an FDA 510(k) clearance letter for a device called "ScannerSide DoseCheck." It doesn't contain information about the device's technical specifications, acceptance criteria, or the study conducted to prove it meets those criteria. The letter primarily states that the device has been determined to be substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe acceptance criteria, nor does it detail a study proving device performance against such criteria. It's a regulatory clearance, not a technical performance report.
To answer your request, I would need a document from Right Dose Inc. (the manufacturer) that details their V&V (Verification and Validation) study for the ScannerSide DoseCheck device, including the testing methodology, acceptance criteria, and study results.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2017
Right Dose Inc. % William Moore, M.D. Official Correspondent 49 Amherst Road PORT WASHINGTON NY 11050
Re: K171261
Trade/Device Name: ScannerSide DoseCheck Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 3, 2017 Received: August 7, 2017
Dear Dr. Moore:
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,
For
Robert Ochs, Ph.D. 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) K171261
Device Name ScannerSide DoseCheck
Indications for Use (Describe)
Scannerside Dose check is intended for providing Computed Tomographic (CT) Dose Check feature to CT X-ray systems. The Scannerside Dose Check is specifically indicated for providing the Computed Tomography Dose Check feature with notifies and alerts the CT equipment operators, prior to a scan, if the estimated dose is above a predefined threshold. This device is intended for CT scanners not equipped with this functionality. The device is indicated for use by professional personnel.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.