(27 days)
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No
The provided text describes a standard digital radiographic system and does not mention any AI or ML capabilities, image processing features, or performance studies related to AI/ML algorithms.
No
The device is described as a diagnostic radiographic system used to take exposures for diagnosis, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device permits a "qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures." The word "diagnostic" directly indicates its use for diagnosis.
No
The device is described as a "Digital Radiographic System with a universal stand for automatic delector positioning," which clearly indicates it includes hardware components (radiographic system, stand, detector).
Based on the provided information, the Xplorer 1800 Digital Radiographic System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Xplorer 1800 is a Digital Radiographic System. This means it uses X-rays to create images of the internal structures of the body. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
- Intended Use: The intended use describes taking radiographic exposures of various body parts on patients. This is consistent with an in vivo imaging device.
Therefore, the Xplorer 1800 falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Xplorer 1800 Digital Radiographic System with a universal stand for automatic delector positioning (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 heatto-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric palients. Applications can be performed with patient sitling, standing or lying in prone or supine positions.
The Xplorer 1800 (510k submission device) is not intended for mammography.
Product codes
KPR, MQB
Device Description
Xplorer 1800 Digital Radiographic System with a universal stand for automatic detector positioning
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
qualified/trained doctor or technologist; stationary radiography system
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes the department's name in blue, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written in a clear, sans-serif font. To the left of the text is a stylized graphic, also in blue, which appears to be a symbolic representation of the department.
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: K063247
Trade/Device Name: Xplorer 1800 Digital Radiographic System with a universal stand for Automatic detector positioning
Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: October 24, 2006 Received: October 26, 2006
Dear Ms. Samarappuli:
This letter corrects our substantially equivalent letter of November 22, 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
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 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
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 1800 Digital Radiographic System with universal stand
Indications for Use
510(k) Number (if known): K063247
Device Name: Xplorer 1800 Digital Radiographic System with a universal stand for automatic detector positioning
Indications for Use:
The Xplorer 1800 Digital Radiographic System with a universal stand for automatic delector positioning (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 heatto-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric palients. Applications can be performed with patient sitling, standing or lying in prone or supine positions.
The Xplorer 1800 (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)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, | |
| and Urological Devices | |
| 510(k) Number | K063247 |