XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM

K033066 · Xitec Holdings, LLC · OXO · Nov 12, 2003 · Radiology

Device Facts

• Record ID: K033066
• Device Name: XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
• Applicant: Xitec Holdings, LLC
• Product Code: OXO · Radiology
• Decision Date: Nov 12, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient extremities.

Device Story

The XiScan 4000 is a compact, mobile, mini C-arm fluoroscopic X-ray system. It captures X-ray images of patient extremities. The system operates in manual or automatic exposure rate control (AERC) modes, offering low-dose and standard-dose settings. It features touchscreen controls for managing patient information and image storage. The device is used by clinicians to visualize extremities; output is displayed on-screen to assist in clinical decision-making during procedures. It provides diagnostic imaging benefits through mobile, compact hardware.

Clinical Evidence

Bench testing only. No clinical data provided. Bench test comparison confirmed that patient X-ray exposure rates for imaging various anatomies are similar to the predicate device.

Technological Characteristics

Mobile mini C-arm fluoroscopic X-ray system. Features manual and automatic exposure rate control (AERC) modes with low-dose and standard-dose options. Includes touchscreen interface for image storage and patient data management. System is transportable.

Indications for Use

Indicated for fluoroscopic imaging of patient extremities.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• XiScan 6000 Imaging System (K003568)

Submission Summary (Full Text)

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NOV 1 2 2003

## 04301 510(k) Summary for

### XiScan 4000 Imaging System

#### 1. SPONSOR

XiTec Holdings LLC 4 New Park Road East Windsor, CT 06088

Contact Person: Mr. Steven Hanright 860-292-7055 Telephone:

September 26, 2003 Date Prepared:

#### DEVICE NAME 2.

Proprietary Name: XiScan 4000 Transportable Imaging System Common/Usual Name: Fluoroscopic mini C-arm systems Image-intensified fluoroscopic X-ray system Classification Name:

#### PREDICATE DEVICE 3.

XiScan 6000 Imaging System (K003568)

#### INTENDED USE 4.

The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient extremities.

#### న. DEVICE DESCRIPTION

The XiScan 4000 Transportable Imaging System is a compact, mobile, mini C-arm system specifically designed for fluoroscopic imaging of patient extremities. The XiScan 4000 Imaging System can be operated in either manual or automatic exposure rate control (AERC) modes, with options of reduced radiation LOW DOSE and high resolution STANDARD DOSE when using AERC. The XiScan 4000 offers a range of functions for image manipulations. It features touchscreen controls to manage on-screen patient information and image storage.

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# 5033966

#### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The XiScan 4000 Transportable Imaging System has the same intended use, and similar technical specifications, as compared to the predicate device. Both devices are mobile mini C-arm systems with similar technique factors, SIDs, field-of-view sizes, and image enhancement options. A bench test comparison of the devices confirmed that the patient X-ray exposure rates for imaging various anatomies are similar. Based on these comparisons, the XiScan 4000 Transportable Imaging System is substantially equivalent to the XiScan 6000 Imaging System.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 2 2003

Xitec Holding, LLC % Mr. Daniel J. Dillion, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K033066 Trade/Device Name: XiScan 4000 Transportable Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: 90 JAA Dated: October 22, 2003 Received: October 23, 2003

Dear Mr. Dillion:

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.

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, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

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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K023066 510(k) Number (if known):

Device Name: __ XiScan 4000 Transportable Imaging System

Indications For Use:

The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient extremities.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Abdom Division of Reproductive. and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use
(Per 21 CFR 801.109)

ાર

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

XiTec Holdings LLC 510(k) XiScan 4000 Imaging System September 26, 2003

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