(27 days)
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.
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This is a letter about a 510(k) clearance for a digital radiographic system, which means it describes the regulatory approval of a medical device. It does not contain information about acceptance criteria or a study proving that the device meets them. There is no information in the document regarding:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, qualifications of experts, or adjudication method for any test set.
- Multi-reader multi-case comparative effectiveness studies or their effect sizes.
- Standalone (algorithm-only) performance studies.
- Types of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document is a notification of substantial equivalence for the "Xplorer 1500 Digital Radiographic System with Stand" to legally marketed predicate devices. It outlines the intended use of the device and its regulatory classification.
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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.
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Protecting and Promoting Public Health.
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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
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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 Devices510(k) Number | K063246 |
|---|---|
| ----------------------------------------------------------------------------------- | --------- |
N/A