(50 days)
Not Found
Not Found
No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets, which are typical for AI/ML devices.
No
The device is described as an "x-ray system" for "taking diagnostic radiographic exposures," indicating its purpose is for diagnosis, not therapy.
Yes
The device is described as "taking diagnostic radiographic exposures," which indicates its use in diagnosing medical conditions by producing images for diagnostic purposes.
No
The device description explicitly states it is a "stationary x-ray system with CCD imager," indicating it includes hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device, the Xplorer 1600, is an X-ray system used to take images of the human body directly.
- The intended use clearly describes diagnostic radiographic exposures of various body parts. This is an in-vivo imaging technique, not an in-vitro diagnostic test.
The information provided describes a standard medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Xplorer 1600 is intended for use by a qualified/trained doctor or technologist on both adult and pedial.inc patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremilies, and other body parts but not mammography. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.
Product codes
MQB
Device Description
Xplorer 1600 A stationary x-ray system with CCD imager
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremilies, and other body parts but not mammography
Indicated Patient Age Range
adult and pedial.inc 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
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. Robin Winsor Chief Technical Officer Imaging Dynamics Company Limited 151, 2340 Pegasus Way NE Calgary, Alberta, T3G 3X5 CANADA
Re: K042041
Trade/Device Name: Xplorer 1600 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 28, 2004 Received: August 2, 2004
AUG 23 2013
Dear Mr. Winsor:
This letter corrects our substantially equivalent letter of September 17, 2004.
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
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Special 510k Submission Xplorer 1600 A stationary x-ray system with CCD imager
Substantial Equivalency
Indications for Use:
The Xplorer 1600 is intended for use by a qualified/trained doctor or technologist on both adult and pedial.inc patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremilies, and other body parts but not mammography. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
ું:
10 September 2004
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
| PRESCRIPTION USE | ✓ |
|---|---|
| OR | OVER-THE-COUNTER |
(Division Sign-Off)
| Division of Reproductive, Abdominal, and Radiological Devices | (DIVISION SIGN-OFF) |
|---|---|
| 510(k) Number | K04-2011 |
| 11 |
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