QV-9000 UNIVERSAL SYSTEM

K083181 · Quantum Medical Imaging, LLC · KPR · Nov 26, 2008 · Radiology

Device Facts

• Record ID: K083181
• Device Name: QV-9000 UNIVERSAL SYSTEM
• Applicant: Quantum Medical Imaging, LLC
• Product Code: KPR · Radiology
• Decision Date: Nov 26, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The QV-9000 Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.

Device Story

Stationary X-ray system for general radiographic imaging of skull, spine, chest, thorax, abdomen, and extremities. System comprises floor-mounted vertical support column, rotating 'C' arm, image receptor, X-ray tube, and collimator. Compatible with digital or non-digital (film) image receptor cabinets. Operated by clinical staff in radiology settings to acquire diagnostic images. Device modifications qualified via design control and risk analysis procedures.

Clinical Evidence

Bench testing only; no clinical data provided. Verification and validation testing methods and results were utilized to qualify device modifications.

Technological Characteristics

Stationary radiographic system; floor-mounted vertical support column; rotating 'C' arm; X-ray tube; collimator; compatible with digital or film image receptor cabinets. Class II device (21 CFR 892.1680).

Indications for Use

Indicated for acquiring radiographic images of various anatomical regions of the human body in patients requiring diagnostic X-ray imaging.

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

• Quantum Medical Imaging, LLC QV-800 Universal System (K023008)

Submission Summary (Full Text)

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K083181

Special 510(k) Premarket Notification: Device Modificatio QV-9000 Universal System

# 510(k) Summary

| Trade Name: | QV-9000 Universal System | NOV 2 6 200- |
|---------------------|-------------------------------------------------------------------------------------------------------------------------|--------------|
| Sponsor: | Quantum Medical Imaging, LLC<br>2002-B Orville Drive North<br>Ronkonkoma, NY 11779-7661<br>FDA Registration No. 2438474 | |
| Device Common Name: | Stationary X-ray System | |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. | |
| Predicate Device: | K023008 -- Quantum Medical Imaging, LLC QV-800 Universal System | |

## Product Description:

The QV-9000 Universal System is a stationary, general purpose, X-ray imaging system used for acquiring radiographic exposures of various parts of the body including the skull, spinal column, chest, thorax, abdomen and extremities. The QV-9000 Universal System incorporates a floor-mounted vertical support column, with an attached rotating 'C' arm, an image receptor, an X-ray tube and collimator. The QV-9000 Universal System is compatible for use with either a digital or non-digital (film type) image receptor cabinet

## Indications for Use:

The QV-9000 Universal System is a stationary radiographic system imaging system used for acquiring radiographic images of various anatomical regions of the human body.

## Safety and Performance:

This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Quantum Medical Imaging, LLC has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. A description and summary of the verificaion and validation testing methods and results utilized to qualify the device modifications is also included in this submission.

## Conclusion:

Based on the indications for use, technological characteristics, performance testing and comparison to predicate device, the proposed Quantum Medical Imaging, LLC QV-9000 Universal System has been shown to be safe and effective for its intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 2 6 2008

Quantum Medical Imaging, Inc. % Ms. Pamela Papineau, RAC President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432

Re: K083181

Trade/Device Name: QV-9000 Universal System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 24, 2008 Received: October 28, 2008

## Dear Ms. Papineau:

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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## 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 |
| 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 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 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.

hoque In thang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Quantum Medical Imaging, LLC October 24, 2008

Special 510(k) Premarket Notification: Device Modification QV-9000 Universal System

Page 1 of 1

510(k) Number (if known): K083181

Device Name: _ QV-9000 Universal System

Indications for Use:

The QV-9000 Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-the -Counter Use (Per 21 CFR 801 Subpart C)

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amri M. Khany

(Division Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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