XPLORER 1100

K062417 · Imaging Dynamics Company , Ltd. · KPR · Sep 15, 2006 · Radiology

Device Facts

• Record ID: K062417
• Device Name: XPLORER 1100
• Applicant: Imaging Dynamics Company , Ltd.
• Product Code: KPR · Radiology
• Decision Date: Sep 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Xplorer 1100 motorized patient table with digital radiographic detector (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to lake a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient lying in the brone por supplie posilions. The Xplorer 1100 (510k submission device) is not intended for mammography.

Device Story

Xplorer 1100 is a motorized patient table integrated with a digital radiographic detector for stationary X-ray systems. Operated by physicians or technologists in clinical settings; device facilitates head-to-toe diagnostic imaging. Patient positioned prone or supine on table. System captures X-ray signals, converting them into digital radiographic images for clinical review. Output assists healthcare providers in diagnostic decision-making across various anatomical regions. Device benefits patients by enabling efficient, high-quality radiographic examinations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized patient table with integrated digital radiographic detector. Stationary X-ray system component. Class II device. Regulation 21 CFR 892.1680. Product codes KPR, MQB, IZZ.

Indications for Use

Indicated for diagnostic radiographic imaging of skull, spine, chest, abdomen, and extremities in adult and pediatric patients. 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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Public Health Service

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

Ms. Shirantha Samarappuli Manager-Regulatory Affairs Imaging Dynamics Company, Ltd. Suite 151, 2340 Pegasus Way NE CALGARY ALBERTA T2E 8M5 CANADA

AUG 2 0 2013

Re: K062417

Trade/Device Name: Xplorer 1100 Motorized patient table with digital radiographic detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB, and IZZ Dated: August 15, 2006 Received: August 18, 2006

Dear Ms. Samarappuli:

This letter corrects our substantially equivalent letter of September 15, 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 (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

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 1100 motorized patient table with Digital Radiographic detector

## Indications for Use

## 510(k) Number (if known): 长۵6コギ17

Device Name: Xplorer 1100 motorized patient table with digital radiographic detector

Indications for Use:

The Xplorer 1100 motorized patient table with digital radiographic detector (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to lake a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient lying in the brone por supplie posilions.

The Xplorer 1100 (510k submission device) is not intended for mammography.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Part 21 CFR 801 Subpart D)
✓

AND/OR

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

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

Camlipa 4 Neulead for N Bijlen

(Division Sig)
Division of Reproductive, Andommal
and Radiological Devices
510(k) Number K062417