(29 days)
Not Found
Nothing to extract.
No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No.
The device is described as a "Digital Radiographic System" intended for taking "diagnostic radiographic exposures". Its purpose is diagnostic imaging, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system permits a "qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures." The word "diagnostic" directly indicates its intended use for diagnosis.
No
The device description explicitly states "Xplorer 1590 Digital Radiographic System with Motorized Stand," indicating it includes hardware components (a radiographic system and a motorized stand) in addition to any potential software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for taking radiographic exposures of various body parts for diagnostic purposes. This involves imaging the internal structures of the body using X-rays.
- Device Description: It's described as a "Digital Radiographic System with Motorized Stand," which is consistent with medical imaging equipment, not a device used to test samples outside the body.
- Input Imaging Modality: The input modality is "Radiographic," which is a form of medical imaging.
- Anatomical Site: The device is used to image various anatomical sites within the body.
- Patient Age Range: It's used on both adult and pediatric patients, indicating direct interaction with the patient.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological or pathological state. This device does not fit that description. It's a medical imaging device used for in-vivo (within the living body) diagnosis.
N/A
Intended Use / Indications for Use
The Xplorer 1590 Digital Radiographic System with motorized stand (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take 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 sitting, standing or lying in the prone or supine positions.
The Xplorer 1590 (510k submission device) is not intended for mammography.
Product codes
KPR, MOB
Device Description
Xplorer 1590 Digital Radiographic System with Motorized Stand
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified/trained doctor or technologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a blue emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font on the right. The emblem features a stylized human figure with outstretched arms, representing the department's focus on health and well-being.
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: K062405
Trade/Device Name: Xplorer 1590 Digital Radiographic System with Motorized Stand Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: August 15, 2006 Received: August 17. 2006
Dear Ms. Samarappuli:
This letter corrects our substantially equivalent letter of September 13, 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
1
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 (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
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Special 510k Submi: Xplorer 1590 Digital Radiographic System with Motorized Stand
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Xplorer 1590 Digital Radiographic System with Motorized Stand
Indications for Use:
The Xplorer 1590 Digital Radiographic System with motorized stand (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take 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 sitting, standing or lying in the prone or supine positions.
The Xplorer 1590 (510k submission device) is not intended for mammography.
David G. Simpson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K162405
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)