K Number
K062634
Device Name
ORTHOXP
Date Cleared
2006-10-06

(30 days)

Product Code
Regulation Number
892.1680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
OrthoXP digital radiographic system
More Information

Not Found

Not Found

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of these technologies.

No
The device is described as taking "diagnostic radiographic exposures" which indicates an imaging device used for diagnosis, not therapy.

Yes
The "Intended Use / Indications for Use" states that the device is "intended for use... for taking diagnostic radiographic exposures".

No

The device description explicitly states "OrthoXP digital radiographic system," which implies a hardware component (the radiographic system) in addition to any potential software. The intended use also describes taking "diagnostic radiographic exposures," which requires hardware.

Based on the provided information, the OrthoXP is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD devices are used to examine specimens taken from the human body. The intended use of the OrthoXP is to take diagnostic radiographic exposures of various body parts directly on the patient. This is an in-vivo (within the living body) diagnostic method, not in-vitro (in glass, referring to tests performed outside the body).
  • The description focuses on imaging the patient's anatomy. There is no mention of analyzing biological samples like blood, urine, tissue, etc., which is the hallmark of IVD devices.

Therefore, the OrthoXP is a medical imaging device used for diagnostic radiography, not an IVD.

N/A

Intended Use / 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.

Product codes

KPR, MQB

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

x-ray system

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

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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.

Image /page/0/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top. Below that is the text "PA" in large letters. Below that is the text "Centennial" in a curved font. There are three stars at the bottom of the logo.

Protecting and Promoting Public Health

1

Page 2 -

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
Other240-276-0100

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 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) |

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(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices[Signature]
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