CPI RAD VISION, MODEL VZW2944XX-YY

K083224 · Communications & Power Industries Canada, Inc. · MQB · Mar 24, 2009 · Radiology

Device Facts

• Record ID: K083224
• Device Name: CPI RAD VISION, MODEL VZW2944XX-YY
• Applicant: Communications & Power Industries Canada, Inc.
• Product Code: MQB · Radiology
• Decision Date: Mar 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CPI RAD VISION is a full featured Radiographic Flat Panel Digital Imaging System for X-ray Generator and Acquisition of digital radiography. The CPI RAD VISION is configurable to any high resolution (3K x 3K) Solid State X-Ray Imager (SSXI) presently in the market. It is intended to replace conventional film screen systems. The CPI RAD VISION allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremities. The CPI RAD VISION enables a qualified operator to acquire, process, and display images with for the benefit of obtaining an optimal diagnostic product. The CPI RAD VISION system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. This device is not intended for mammographic, fluoroscopic and or angiographic applications. The CPI RAD VISION system will not include the X-Ray system itself.

Device Story

CPI RAD VISION is a digital radiography acquisition system; replaces conventional film-screen systems. Inputs: X-ray signals from compatible high-resolution (3K x 3K) Solid State X-Ray Imagers (SSXI). Components: Flat Panel Detector, medical-grade isolation transformer (ISO-BOX), LCD monitor, and workstation computer. Operation: Qualified operator controls X-ray generator and manages image acquisition, processing, storage, display, and distribution via a single user interface. Output: Digital images for diagnostic review; supports network transmission and laser printing. Used in clinical settings; provides optimized diagnostic images to assist healthcare providers in clinical decision-making. Benefits: Enables transition from analog to digital radiography, improving workflow and image management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes Flat Panel Detector, medical-grade isolation transformer, LCD monitor, and workstation. Interfaces with high-resolution (3K x 3K) Solid State X-Ray Imagers (SSXI). Connectivity via network port for DICOM communication. Software-based image acquisition, processing, and distribution. No specific material standards or algorithm architecture details provided.

Indications for Use

Indicated for digital radiographic examinations of skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle, and extremities in adult and pediatric patients. Contraindicated for mammographic, fluoroscopic, and angiographic applications.

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

• CMT MEDICAL TECHNOLOGIES LTD. SMART RAD (K003438)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Communications & Power Industries. The logo is a stylized version of the letters CPI. Below the logo, the words "Communications & Power Industries" are written in a smaller font. Below that, the words "communications & medical products division" are written in an even smaller font.

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MAR 2 4 2009

Section 5

# 510(k) Summary of Safety and Effectiveness

| Date Prepared: | October 27, 2008 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Contact Person: Norm Morikawa | |
| Address: | Communications & Power Industries Canada Inc.<br>Communications & Medical Products Division<br>45 River Drive, Georgetown, Ontario, L7G 2J4, Canada |
| Telephone: | 905-877-0161 |
| Fax: | 905-877-5327 |
| Device Trade Name: | CPI RAD VISION |
| Common Name: | Digital Radiography |
| Classification Name: | Solid State x-ray Imager (flat panel/digital imager) |

### Device Description:

The CPI RAD VISION is a component of a complete radiographic x-ray system. The CPI RAD VISION provides a single user interface for control of the x-ray generator and all digital imaging functions required by a radiographic acquisition modality (acquisition, processing, storage, display, and distribution of images).

The CPI RAD VISION consists of Flat Panel Detector, ISO-BOX (Medical Grade Isolation Transformer), LCD Monitor, and a workstation (computer) with x-ray generator interface, image receptor interface, and network port for communications with supported DICOM devices.

### Intended Use:

The CPI RAD VISION is a full featured Radiographic Flat Panel Digital Imaging System for X-ray Generator and Acquisition of digital radiography. The CPI RAD VISION is configurable to any high resolution (3K x 3K) Solid State X-Ray Imager (SSXI) presently in the market. It is intended to replace conventional film screen systems.

The CPI RAD VISION allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic

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Image /page/1/Picture/0 description: The image shows the logo for Communications & Power Industries. The logo consists of the letters CPI in a stylized font, with the words "Communications & Power Industries" written below it. Below that, the words "communications & medical products division" are written in a smaller font. The logo is black and white.

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regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremities.

The CPI RAD VISION enables a qualified operator to acquire, process, and display images with for the benefit of obtaining an optimal diagnostic product. The CPI RAD VISION system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network.

This device is not intended for mammographic, fluoroscopic and or angiographic applications. The CPI RAD VISION system will not include the X-Ray system itself.

### Conclusion drawn from comparison:

The CPI RAD VISION can be considered to be substantially equivalent to:

CMT MEDICAL TECHNOLOGIES LTD. SMART RAD 510 (k) - K003438

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2009

Mr. Norm Morikawa QA Manager/Regulatory Affairs Communications & Power Industries Canada, Inc. 45 River Drive Georgetown, Ontario, L7G 2J4 CANADA

Re: K083224

Trade/Device Name: CPI RAD VISION Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MOB Dated: February 24, 2009 Received: February 25, 2009

Dear Mr. Morikawa:

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 (OS) 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 os 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Laura B. Morris

anine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): Not known at this time

K08 3234

Device Name: CPI RAD VISION

Indications For Use:

The CPI RAD VISION is a full featured Radiographic Flat Panel Digital Imaging System for Xray Generator and Acquisition of digital radiography. The CPI RAD VISION is configurable to any high resolution (3K x 3K) Solid State X-Ray Imager (SSXI) presently in the market. It is intended to replace conventional film screen systems.

The CPI RAD VISION allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremities.

The CPI RAD VISION enables a qualified operator to acquire, process, and display images with for the benefit of obtaining an optimal diagnostic product. The CPI RAD VISION system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. This device is not intended for mammographic, fluoroscopic and or angiographic applications. The CPI RAD VISION will not include the X-Ray system itself.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aorri MWhaz

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

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