RADVISION ET DIAGNOSTIC X-RAY SYSTEM

K082064 · Almana Medical Imaging · KPR · Aug 22, 2008 · Radiology

Device Facts

• Record ID: K082064
• Device Name: RADVISION ET DIAGNOSTIC X-RAY SYSTEM
• Applicant: Almana Medical Imaging
• Product Code: KPR · Radiology
• Decision Date: Aug 22, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This radiographic system is 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

Stationary diagnostic X-ray system; consists of tubehead/collimator assembly on ceiling suspension, generator, generator control, and elevating X-ray table. Operated by qualified doctor or technician in clinical setting. Generates X-ray exposures for diagnostic imaging of various body parts. Generator power 32-80 kW; voltage 40-150 kV; current 300-1000 mA; exposure time 1 ms-10 s. Output used by healthcare providers to visualize internal anatomy for clinical decision-making and diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stationary X-ray system; ceiling-mounted tubehead/collimator; elevating table. Generator power 32-80 kW; 40-150 kV range; 300-1000 mA current. Electrical safety per IEC-60601. Complies with 21 CFR 1020.30.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities. Can be used with patient in sitting, standing, prone, or supine positions.

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

• RADVISION E and RADVISION EU Diagnostic X-Ray Systems (K072659)

Submission Summary (Full Text)

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510(k) Summary 510(k) Number KO82064 Almana Medical Imaging P.O. Box 3568 Alkhobar 31952 Kingdom of Saudi Arabia T: [phone] F: [phone] Date Prepared: July 14, 2008 Mohammed Irfanullah Farooqui, Sales and Marketing Manager Contact:

- 1. Identification of the Device: Proprietary-Trade Name: RADVISION ET Diagnostic X-Ray Systems Classification Name: Stationary x-ray system, Product Code 90 KPR Common/Usual Name: Stationary Diagnostic X-Ray
- Equivalent legally marketed device: RADVISION E and RADVISION EU Diagnostic X-Ray 2. Systems, K072659.
- 3. Indications for Use (intended use) This radiographic system is 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: This diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a ceiling suspension along with a generator, generator control, and an elevating x-ray table. Power ratings for the available generators are in the rage of 32 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 -100 mA. Exposure time is 1 ms - 10 s.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices. Rad Vision E Rad Vision eu RADVISION ET

Image /page/0/Figure/7 description: The image shows three different X-ray machines. The machine on the left has a horizontal table with a vertical X-ray tube above it. The machine in the center has a similar table, but the X-ray tube is mounted on a vertical column. The machine on the right is a more modern version of the X-ray machine, with a digital display.

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## 6. Substantial Equivalence Chart

| Characteristic | RADVISION E and<br>RADVISION EU<br>K072659 | RADVISION ET |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Intended Use: | Intended for use by a<br>qualified/trained doctor<br>or technician on both<br>adult and pediatric<br>subjects for taking<br>diagnostic radiographic<br>exposures of the skull,<br>spinal column, chest,<br>abdomen, extremities,<br>and other body parts.<br>Applications can be<br>performed with the<br>patient sitting, standing,<br>or lying in the prone or<br>supine position. | SAME |
| Configuration | Column mount | Ceiling suspension |
| Performance<br>Standard | 21 CFR 1020.30 | SAME |
| Generator | High frequency made<br>by Sedecal | Uses same generator<br>made by Sedecal |
| Electrical safety | Electrical Safety per<br>IEC-60601. UL listed | SAME |

## 7. Conclusion

After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of Almana Medical Imaging that the RADVISION ET Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 2 2008

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

Re: K082064

Trade/Device Name: RADVISION ET Diagnostic X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: July 15, 2008 Received: July 23, 2008

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): K082064

Device Name: RADVISION ET Diagnostic X-Ray System

Indications For Use:

This Radiographic System is 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

Over-The-Counter Use (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)

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Arzu Tan Wh
(Division Sign Off)

(Divis Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __

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