DRX-REVOLUTION MOBILE X-RAY SYSTEM

K120062 · Carestream Health, Inc. · IZL · Apr 13, 2012 · Radiology

Device Facts

• Record ID: K120062
• Device Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Applicant: Carestream Health, Inc.
• Product Code: IZL · Radiology
• Decision Date: Apr 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

Device Story

DRX-Revolution is a mobile digital radiography (DR) system for diagnostic imaging outside stationary x-ray rooms. System includes self-contained x-ray generator, flat-panel detector (wireless capable), imaging display, and software. Mounted on battery-powered, motorized cart for transport between patient areas. Operated by clinicians to perform exams like in-bed chest projections. System captures images via flat-panel detector or exposes CR phosphor screens/film. Operator console with touch screen provides image processing. Output used by healthcare providers for diagnostic decision-making; mobile design facilitates rapid imaging at point-of-care, improving patient access to diagnostic services.

Clinical Evidence

Clinical evidence based on a reader study of clinical image pairs comparing subject device to predicate. Study conducted per FDA guidance for solid state imaging devices. Results demonstrated diagnostic capability is statistically equivalent to or better than the predicate device.

Technological Characteristics

Mobile x-ray system with x-ray generator, tube, collimator, and touch screen console. Digital flat-panel detector for image capture; compatible with CR phosphor screens and film. Battery-powered motorized cart. Software provides image processing. No specific material standards or algorithm architecture details provided.

Indications for Use

Indicated for radiographic x-ray examinations in all pediatric and adult patients across all clinical treatment areas.

Regulatory Classification

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Shimadzu MobileDaRt (K041763)

Submission Summary (Full Text)

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K120062

# Carestream

APR 1 3 2012

## "510(k) Summary"

510(k) Owner Name: 510(k) Owner Address:

510(k) Owner Phone: 510(k) Owner Fax:

Contact Person & Info:

Carestream Health, Inc. 150 Verona Street Rochester, New York 14608

585 627-6543 585 454-1894

Carolyn Wagner Regulatory Affairs Manager, Medical Imaging [e-mail] 585-627-6588

Date Summary Prepared:

Device Trade Name: Device Common Name: Classification Name:

Device Class: Device Code: Regulation Number:

Predicate Device:

January 5, 2011

DRX-Revolution Mobile X-ray System mobile x-ray system Mobile x-ray system

Class II IZL 21 CFR 892.1720

Shimadzu MobileDaRt Manufactured by Shimadzu Corp. 510(k) No. - K041763 (July 13, 2004)

#### Device Description:

The DRX-Revolution Mobile X-ray System (also referred to as the DRX-Revolution) is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. The DRX-Revolution consists of a self contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of a standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can ' also be used to expose CR phosphor screens or film.

#### Indications for Use / Intended Use:

The Indications for Use for the device, as described in its labeling, are:

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"The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas."

The intended use for this device, as determined by descriptions and the proposed labeling contained in this submission, is similar to the Indications for Use statement provided above. The DRX-Revolution is a mobile system used to generate and control x-rays for diagnostic procedures. We believe that the DRX-Revolution and the predicate device have the same intended use.

The Indications for Use for the subject device is different than the predicate device, but these differences do not alter the intended diagnostic use of the device. Differences are appropriately characterized as descriptive, and the intended use remains unchanged. Any variation in features or technical specifications have been identified and addressed through testing (described below) to support a substantial equivalence determination.

#### Comparison of Technological Characteristics:

The DRX-Revolution Mobile X-ray System is substantially equivalent to the predicate device, the Shimadzu MobileDaRt (MUX-100D). The DRX-Revolution Mobile X-rav System and the Shimadzu MobileDaRt system both consist of an x-ray generator, x-rav tube, collimator, and graphical user interface on an operator console with touch screen monitor. These components are mounted on a motorized cart that is battery powered to enable the device to be moved from location to location. Both systems utilize a digital flat panel detector for image capture and can also be used to expose CR storage phosphor or film cassettes. Both systems have operator console software with image processing capability.

#### Discussion of Testing

The performance characteristics and operation / usability of the DRX-Revolution system were evaluated in non-clinical (bench) testing. These studies demonstrated the intended workflow, related performance, overall function, verification and validation of requirements for intended use, shipping performance, and reliability of the DRX-Revolution system including both software and hardware requirements. Non-clinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.

A concurrence study of clinical image pairs was performed in accordance with FDA guidance document "Guidance for the Submission of 510(k)'s for Solid State Imaging Devices" to demonstrate the diagnostic capability of the DRX-Revolution system. Results of the Reader Study indicated that the diagnostic capability of the DRX-Revolution Mobile X-ray System is statistically equivalent to or better than that of the predicate device. These results support a substantial equivalence determination.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue -Document-Control-Room -- WO66-G609 Silver Spring, MD 20993-0002

Ms. Carolyn Wagner Regulatory Affairs Manager Carestream Health, Inc. 150 Verona Street ROCHESTER NY 14608

Re: K120062

Trade/Device Name: DRX-Revolution Mobile X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: March 2, 2012 Received: March 5, 2012

#### Dear Ms. Wagner:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

APR 1 3 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will-allow-you-to-begin-marketing-your-device as described in-your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):

Device Name: _ DRX-Revolution Mobile X-ray System

Indications for Use:

The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

.

(Division Sign-Off)
Division of Radiological Devices
Electromagnetic Device Evaluation and Safet

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K170062

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