RAD VISION, MODELS E AND EU

K072659 · Almana Medical Imaging · KPR · Nov 15, 2007 · Radiology

Device Facts

• Record ID: K072659
• Device Name: RAD VISION, MODELS E AND EU
• Applicant: Almana Medical Imaging
• Product Code: KPR · Radiology
• Decision Date: Nov 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

These Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position..

Device Story

Rad Vision E and Rad Vision eu are stationary diagnostic X-ray systems. Rad Vision E features a fixed column with track-mounted movement; Rad Vision eu utilizes a floor-to-wall column with a turnable swivel arm. Both systems include a tubehead and collimator. Operated by qualified doctors or technicians in clinical settings. Systems support patient positioning (sitting, standing, prone, supine) for radiographic exposures. Output consists of diagnostic X-ray images used by clinicians to assess anatomy and pathology. Benefits include versatile patient positioning and efficient radiographic procedures.

Clinical Evidence

Bench, test laboratory, and clinical testing performed. Results indicate the device is as safe and effective as the predicate.

Technological Characteristics

Stationary diagnostic X-ray system. Rad Vision E: fixed column on track. Rad Vision eu: floor-to-wall column with swivel arm. Includes tubehead and collimator. Operates as a conventional radiographic system.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities. No specific contraindications listed.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Optima URS Universal Radiographic System (K012546)

Submission Summary (Full Text)

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### 510(k) Summary 510(k) Number Ko72659 Almana Medical Imaging P.O. Box 3568 Alkhobar 31952 NOV 1 5 2007 Kingdom of Saudi Arabia T: [phone] F: [phone] Date Prepared: September 11, 2007 Mohammed Irfanullah Farooqui, Sales and Marketing Manager Contact:

- l . Identification of the Device: Proprietary-Trade Name: Rad Vision E and Rad Vision eu Diagnostic X-Ray Systems Classification Name: Stationary x-ray system, Product Code 90 KPR Common/Usual Name: Stationary Diagnostic X-Ray
- 2. Equivalent legally marketed device: "Optima URS" Universal Radiographic System K012546
- 3. Indications for Use (intended use) These Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position ..
- 4. Description of the Device: The Rad Vision E is a standard configuration fixed column diagnostic radiographic system. The column can move right or left on a track and the tube head can move up and down. Rad Vision eu is a universal swivel arm X-ray system. It is easy to operate and permits a swift radiographic procedure, a feature which applies to all conventional exposure techniques on all parts of the body. The system is composed of a floor-to-wall column and a turnable arm. On the arm is the tubehead with a collimator mounted to it. All components required for a complete system are supplied. With the patient table, the patient can be moved into any required position without the need for repositioning. Therefore it offers the same advantages as a bucky radiography table. Owing to the large vertical movement of the swivel arm patients in the standing position can be examined from head to feet.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices.

Image /page/0/Figure/6 description: The image shows two different models of Rad Vision machines. The model on the left is labeled "Rad Vision E" and the model on the right is labeled "Rad Vision eu". Both models appear to be X-ray machines with tables for patients to lie on. The "Rad Vision eu" model has a more complex design with a vertical column and a rotating arm.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Almana Medical Imaging % Mr. Daniel Kamm Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015

Re: K072659

Trade/Device Name: Rad Vision E and Rad Vision eu Diagnostic X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: September 17, 2007 Received: September 24, 2007

### Dear Mr. Kamm:

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 (PMA). 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Brogdon

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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# Indications for Use

510(k) Number (if known): K072659

Device Name: Rad Vision E and Rad Vision eu Diagnostic X-Ray Systems

Indications For Use:

These Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position..

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lori M. Whing

Division of Reproductive, Abdominal an Radiological Devices 510(k) Number _

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