XPLORER 1600 PLUS

K062586 · Imaging Dynamics Company , Ltd. · MQB · Sep 29, 2006 · Radiology

Device Facts

• Record ID: K062586
• Device Name: XPLORER 1600 PLUS
• Applicant: Imaging Dynamics Company , Ltd.
• Product Code: MQB · Radiology
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Xplorer 1600 Plus is intended for use by a qualified/trained doctor or technologist on both adult and pediatric palients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatic patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The Xplorer 1600 Plus (510k submission device) is not intended for mammography.

Device Story

Xplorer 1600 Plus is a stationary digital radiographic system; captures X-ray images for diagnostic purposes. Operated by qualified doctors or technologists in clinical settings. System acquires radiographic exposures of various body parts; supports multiple patient positions (sitting, standing, prone, supine). Output consists of digital radiographic images for clinical review and diagnostic decision-making. Benefits include efficient acquisition of diagnostic images for patient assessment. Device is not intended for mammography applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stationary digital radiographic system; 21 CFR 892.1680; Product Code MQB. System components include X-ray source and digital detector for image acquisition. Designed for general radiographic applications excluding mammography.

Indications for Use

Indicated for diagnostic radiographic imaging of skull, spine, chest, abdomen, and extremities in adult and pediatric patients. Positioning includes sitting, standing, prone, or supine. 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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## 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. Shirantha Samarappuli Manager, Regulatory Affairs Imagingdynamics Co Suite 151, 2340 Pegasus Way NE Calgary, Alberta, T2E 8M5 CANADA

Re: K062586 Trade/Device Name: Explorer 1600 Plus Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 29, 2006 Received: September 1, 2006

AUG 23 2013

Dear Mr. Samarappuli:

This letter corrects our substantially equivalent letter of September 29, 2006.

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 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 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

Janine M. Morri 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 Plus Digital Radiographic System

Indications for Use

510(k) Number (if known): 10002586

Device Name: Xplorer 1600 Plus digital radiographic system

Indications for Use:

The Xplorer 1600 Plus is intended for use by a qualified/trained doctor or technologist on both adult and pediatric palients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatic patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.

The Xplorer 1600 Plus (510k submission device) is not intended for mammography.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Part 21 CFR 801 Subpart D)

ANDIOR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

David A. Lippman

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K062586

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