OnSight 3D Extremity System

K173478 · Carestream Health, Inc. · JAK · Jan 19, 2018 · Radiology

Device Facts

• Record ID: K173478
• Device Name: OnSight 3D Extremity System
• Applicant: Carestream Health, Inc.
• Product Code: JAK · Radiology
• Decision Date: Jan 19, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.

Device Story

OnSight 3D Extremity System performs computed tomography (CT) and projection x-ray imaging of extremities. Device captures x-ray data from upper and lower extremities; processes data to generate 3D volumetric images and 2D projection images. Used in clinical settings by trained healthcare professionals. Output displayed on workstation for diagnostic review by physicians to assist in clinical decision-making regarding extremity pathology. Benefits include high-resolution 3D visualization of extremity anatomy for improved diagnostic accuracy compared to standard 2D imaging.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Computed tomography x-ray system; 21 CFR 892.1750; Class II; Product Code JAK. System utilizes x-ray source and detector array for volumetric data acquisition. Includes software for image reconstruction and processing. Operates as a standalone imaging system.

Indications for Use

Indicated for x-ray computed tomography and projection x-ray imaging of upper and lower extremities in adult and pediatric patients aged 12 and older.

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.

Predicate Devices

• Carestream Health, Inc. OnSight 3D Extremity System (K163360)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Carestream Health, Inc. % Ms. Victoria Wheeler Sr. Regulatory Affairs Manager 150 Verona Street ROCHESTER NY 14608

January 19, 2018

Re: K173478

Trade/Device Name: OnSight 3D Extremity System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 22, 2017 Received: December 26, 2017

Dear Ms. Wheeler:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara 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) K173478

Device Name OnSight 3D Extremity System

## Indications for Use (Describe)

The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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