(30 days)
The OrthoXP is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatic patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.
The OrthoXP (510k submission device) is not intended for mammography.
OrthoXP digital radiographic system
This appears to be a 510(k) clearance letter for the OrthoXP digital radiographic system, which details its indications for use but does not contain information about acceptance criteria or the specific studies demonstrating performance against such criteria. The letter confirms the device's substantial equivalence to a predicate device but does not include the detailed performance study information typically found in a 510(k) summary or the full submission.
Therefore,Based on the provided document, the requested information regarding acceptance criteria and the study proving the device meets those criteria is not available. The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a legally marketed predicate device but does not detail the specific performance studies that led to this determination.
To answer your questions, one would typically need access to the 510(k) summary or the full 510(k) submission, which would contain the performance data and acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT -6 2006
Mr. Shirantha Samarappuli Manager-Regulatory Affairs Imaging Dynamics Company Ltd. Suite 151, 2340 Pegasus Way NE, Calgary, Alberta, T2E 8M5 CANADA
Re: K062634
Trade/Device Name: OrthoXP digital radiographic system Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: September 1, 2006 Received: September 6, 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 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 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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) 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 Part 801), please contact the 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 Submis OrthoXP Digital Radiographic System
Indications for Use
510(k) Number (if known): K062634
510(k) Number .
Device Name: OrthoXP digital radiographic system
Indications for Use:
The OrthoXP is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatic patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.
The OrthoXP (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 | [Signature] |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------- |
N/A