SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION

K080701 · Shimadzu Corp. · IZL · May 14, 2008 · Radiology

Device Facts

• Record ID: K080701
• Device Name: SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
• Applicant: Shimadzu Corp.
• Product Code: IZL · Radiology
• Decision Date: May 14, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1720
• Device Class: Class 2

Intended Use

This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)

Device Story

MobileDaRt Evolution is a mobile X-ray system designed for bedside or emergency department imaging. It captures radiographic images of patients unable to be transported to a radiology suite. The system supports film, Computed Radiography (CR), and Digital Radiography (DR) modalities. Operated by trained radiologic technologists, the device provides immediate diagnostic imaging to assist clinicians in patient assessment and treatment planning. It functions as a mobile platform for X-ray generation and image acquisition, facilitating point-of-care diagnostics.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mobile X-ray system; supports film, CR, and DR image acquisition; mobile chassis; X-ray generator; 21 CFR 892.1720 classification.

Indications for Use

Indicated for patients in hospital settings who are immobile and outpatients in emergency settings requiring general radiography, CR, or DR imaging.

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

• MobileDaRt (K052636)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Don Karle Director, National Service Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328

MAY 1 4 2008

Re: K080701

Trade/Device Name: MobileDaRt Evolution Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: February 25, 2008 Received: March 11, 2008

## Dear Mr. Karle:

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, therest est conc product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 10(a)/ 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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Craptiance of Compliance of case of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contect CDRF's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/1276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 633-241 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/industry/support/index.html of

Sincerely yours.

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Notification Submission, MobileDaRt Evolution

## SECTION XI.INDICATION FOR USE STATEMENT

510(K) Number (if known):

Yorktown 80701

Device Name: MobileDaRt Evolution

Indications for Use:

- · This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Exposure can be captured on film, CR or Digital Radiography (DR)

Lorge Mirkham

(Divi Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per2l CFR801.109)