(109 days)
Not Found
Not Found
No
The summary describes a dose check feature based on predefined thresholds, with no mention of AI, ML, or related concepts.
No
This device provides a "Dose Check" feature to alert operators about estimated dose levels prior to a CT scan; it does not directly treat or diagnose a medical condition.
No
This device provides a "Dose Check feature" by notifying and alerting operators if the estimated dose is above a predefined threshold, prior to a scan. It monitors and alerts about a parameter (CT dose) but does not diagnose a medical condition or disease in a patient.
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only. The intended use describes a software-like function (dose checking and alerting), but without a device description, it's impossible to confirm if it's purely software or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a "CT Dose Check feature" to CT X-ray systems. This involves monitoring and alerting based on estimated radiation dose prior to a scan. This is a function related to the operation and safety of the imaging equipment itself, not the analysis of biological samples or specimens taken from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status based on sample analysis
- Using reagents or other materials to perform tests on samples
The device's function is focused on the technical parameters and safety aspects of the CT scanning process, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
JAK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Computed Tomographic (CT) X-ray systems
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional personnel
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
§ 892.1750 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the top of the logo.
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.
1
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
2
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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