(27 days)
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Not Found
No
The provided text does not mention AI, ML, or any related concepts in the intended use, device description, or other sections.
No
The device is described as a "Digital Radiographic System" intended for "diagnostic radiographic exposures". Its purpose is to take images for diagnosis, not to treat or cure conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device permits a qualified/trained doctor or technologist to take "diagnostic radiographic exposures," directly indicating its role in diagnosis.
No
The device is described as a "Digital Radiographic System with stand," indicating it includes hardware components (the stand and likely other parts of the radiographic system) 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 diagnostic radiographic exposures of various body parts. This involves imaging the internal structures of the body using X-rays.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The Xplorer 1500 operates by generating and detecting X-rays to create images of the body, which is a form of in vivo (within the living body) diagnostic imaging, not in vitro.
N/A
Intended Use / Indications for Use
The Xplorer 1500 Digital Radiographic System with 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 or standing.
The Xplorer 1500 (510k submission device) is not intended for mammography.
Product codes
IXK, MQB, KPR
Device Description
Xplorer 1500 Digital Radiographic System with Stand
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 patients
Intended User / Care Setting
qualified/trained doctor or technologist; user's 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 (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
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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.
0
Image /page/0/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Shirantha Samarappuli Manager-Regulatory Affairs Imaging Dynamics Company Ltd 151, 2240 Pegasus Way Calgary Alberta T2F 8M5 CANADA
NOV 2 2 2006
Re: K063246
Trade/Device Name: Xplorer 1500 Digital Radiographic System with Stand Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: IXK, MQB and KPR Dated: October 24, 2006 Received: October 26, 2006
Dear Mr. Samarappuli:
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 devoces that have been reclassified in accordance with the provisions of the Federal Food, Drue, and Commence 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. T o general controls provisions of the Act include requirements for annual registration, listing of the pendant manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "FDA" in the center, and "Centennial" below the FDA text. There are three stars below the word Centennial. The logo is surrounded by a circular border.
Protecting and Promoting Public Health.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Dri-Stosunts and your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any i catal statutes and registements, including, but not limited to: registration and listing (21 contply with an the He. 31equirements) in the manufacturing practice requirements as set CI K I at 607), lacemig (21 CDN Pgulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter unfrancer you to begin will be substantial equivalence of your device to a legally premated 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 Part 801), please 11 you done office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Special 510k Submission Xplorer 1500 Digital Radiographic System with vertical Stand
Indications for Use
Kol 3246 510(k) Number (if known):
Device Name: Xplorer 1500 Digital Radiographic System with Stand
Indications for Use:
The Xplorer 1500 Digital Radiographic System with 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 or standing.
The Xplorer 1500 (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 Radiological Devices
| 510(k) Number | K063246 |
|---|---|
| ----------------------------------------------------------------------------------- | --------- |