(28 days)
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.
Xplorer 1600 Plus digital radiographic system
This document is a 510(k) clearance letter from the FDA for a medical device called the "Xplorer 1600 Plus Digital Radiographic System." It does not contain sections on acceptance criteria or detailed study information typically found in a clinical study report. Therefore, I cannot extract the requested information from the provided text.
Specifically, the document:
- Identifies the device: Xplorer 1600 Plus Digital Radiographic System.
- States its intended use: Taking diagnostic radiographic exposures of various body parts in adult and pediatric patients (excluding mammography).
- Confirms regulatory clearance: Substantial equivalence to a legally marketed predicate device.
- Outlines general regulatory requirements.
This type of FDA letter confirms market clearance based on substantial equivalence to an existing device, rather than providing the detailed performance studies and acceptance criteria that you've asked for. Such information would typically be found in the 510(k) submission itself or a separate scientific report.
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Image /page/0/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three overlapping wings, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle, with "DEPARTMENT OF" at the bottom and "USA" at the top.
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
8
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.