ScannerSide DoseCheck

K171261 · Right Dose, Inc. · JAK · Aug 18, 2017 · Radiology

Device Facts

• Record ID: K171261
• Device Name: ScannerSide DoseCheck
• Applicant: Right Dose, Inc.
• Product Code: JAK · Radiology
• Decision Date: Aug 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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 intended for use by professional personnel.

Device Story

ScannerSide DoseCheck is an add-on software/hardware solution for CT scanners lacking integrated dose monitoring. It functions by calculating estimated radiation dose prior to scan initiation; compares estimated dose against user-defined thresholds; triggers notifications or alerts to the operator if thresholds are exceeded. Used in clinical imaging environments by professional personnel (radiologic technologists/physicians). Enables proactive dose management; assists operators in adhering to ALARA principles; reduces risk of unnecessary radiation exposure to patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based dose monitoring system for CT X-ray equipment. Operates as an add-on to existing CT systems to provide dose notification and alert functionality. Connectivity via integration with CT scanner control systems. Rule-based threshold monitoring.

Indications for Use

Indicated for professional personnel operating CT X-ray systems not equipped with dose notification/alert functionality. Provides pre-scan notifications and alerts when estimated radiation dose exceeds predefined thresholds.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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