XPLORER 1600

K042041 · Imaging Dynamics Company Limited · MQB · Sep 17, 2004 · Radiology

Device Facts

• Record ID: K042041
• Device Name: XPLORER 1600
• Applicant: Imaging Dynamics Company Limited
• Product Code: MQB · Radiology
• Decision Date: Sep 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Xplorer 1600 is intended for use by a qualified/trained doctor or technologist on both adult and pedial.inc patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremilies, and other body parts but not mammography. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.

Device Story

Xplorer 1600 is a stationary X-ray system utilizing a CCD imager for digital radiography. Operated by qualified doctors or technologists in clinical settings; system captures diagnostic radiographic exposures of various body parts (skull, spine, chest, abdomen, extremities). Patient positioning includes sitting, standing, or lying (prone/supine). Device transforms X-ray radiation into digital images for clinical review; assists healthcare providers in diagnostic assessment of anatomical structures. Benefits include rapid acquisition of digital radiographic images for clinical decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stationary X-ray system; CCD (Charge-Coupled Device) imager for digital image acquisition; intended for general radiographic applications excluding mammography; supports multiple patient positions (standing, sitting, supine, prone).

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spinal column, chest, abdomen, and extremities. Contraindicated for mammography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

## 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

Mr. Robin Winsor Chief Technical Officer Imaging Dynamics Company Limited 151, 2340 Pegasus Way NE Calgary, Alberta, T3G 3X5 CANADA

Re: K042041

Trade/Device Name: Xplorer 1600 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 28, 2004 Received: August 2, 2004

AUG 23 2013

Dear Mr. Winsor:

This letter corrects our substantially equivalent letter of September 17, 2004.

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

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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 nredicate 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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## Special 510k Submission Xplorer 1600 A stationary x-ray system with CCD imager

## Substantial Equivalency

## Indications for Use:

The Xplorer 1600 is intended for use by a qualified/trained doctor or technologist on both adult and pedial.inc patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremilies, and other body parts but not mammography. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

ું:

10 September 2004

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

| PRESCRIPTION USE | <div style="display:inline-block; vertical-align:top;">✓</div> |
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| OR | OVER-THE-COUNTER |

(Division Sign-Off)

| Division of Reproductive, Abdominal, and Radiological Devices | (DIVISION SIGN-OFF) |
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| 510(k) Number | K04-2011 |
| | 11 |

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