DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE

K111385 · Qubyx Limited · LLZ · Jan 30, 2012 · Radiology

Device Facts

• Record ID: K111385
• Device Name: DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE
• Applicant: Qubyx Limited
• Product Code: LLZ · Radiology
• Decision Date: Jan 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The DELL UltraSharp U3011 with QUBYX PerfectLum is intended to be used in displaying and viewing of digital images, for review and analysis by trained medical practitioners. The DELL UltraSharp U3011 must only be used in conjunction with QUBYX PerfectLum 3.0 These devices must not be used in primary image diagnosis in mammography. The device can not be used for a life-support system.

Device Story

System comprises 30-inch color LCD monitor (DELL UltraSharp U3011) bundled with PerfectLum 3.0 software. Software provides DICOM calibration and AAPM TG18 verification for display. Used by trained medical practitioners in clinical settings for review/analysis of digital medical images. Output is visual display of images; software ensures display function meets DICOM standards via adjustable Look Up Table (LUT). Benefits include standardized image viewing quality for diagnostic review. Not for primary mammography diagnosis or life-support.

Clinical Evidence

No clinical data. Substantial equivalence based on technical characteristics and performance specifications comparison.

Technological Characteristics

30-inch IPS LCD panel; 2560x1600 resolution; 10-bit panel; 370 cd/m2 typical brightness; 1000:1 contrast ratio; 178-degree viewing angle. Includes bundled PerfectLum 3.0 software for DICOM calibration and AAPM TG18 verification. Adjustable Look Up Table (LUT).

Indications for Use

Indicated for trained medical practitioners to display and view digital images for review and analysis. Contraindicated for primary image diagnosis in mammography and use in life-support systems.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• LCD3090WQXI (K083916)

Submission Summary (Full Text)

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K111385

### JAN 3 0 2012

# 510(K) Summary of Safety and Effectiveness

as required by 807.92

1. Company Identification QUBYX Limited 80, rue Marechal Joffre 06000 Nice, France Tel: [phone]

2. Official Correspondent Mr Marc Leppla President and CTO (Chief Technical Officer) [e-mail]

FDA CDRH I WK

MAY 1 7 2011

trakasina

3. Date of Submission May 05, 2011

4. Device Trade name DELL UltraSharp U3011 with QUBYX PerfectLum bundle

5. Common/Usual Name Image display system, Color LCD Monitor, image monitor/display

6. Classification Number Medical displays classified in Class II per 21 CFR 892.2050

7. Predicate device Name: LCD3090WQXI Manufacturer: NEC Display Solutions Ltd 510(k) number: K083916

IC29

1

8. Device description

The DELL UltraSharp U3011 with QUBYX PerfectLum is a 30" color display for medical viewing. It provides 4 mega pixel (2560x1600) resolution with a adjustable Look Up Table and a 10 bit Panel.

It is combined with QUBYX PerfectLum 3.0 and PerfectLum remote QA, a user-friendly DICOM calibration and AAPM TG18 verification software suite. The software allows to set the display function to DICOM, display testpattern and perform acceptance and constancy tests.

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#### 9. Intended use

The DELL UltraSharp U3011 with QUBYX PerfectLum is intended to be used in displaying and viewing of digital images, for review and analysis by trained medical practitioners.

The DELL UltraSharp U3011 must only be used in conjunction with QUBYX PerfectLum 3.0

These devices must not be used in primary image diagnosis in mammography.

The device can not be used for a life-support system.

#### 10. Conclusion

Compared to the predicate device, the U3011 uses a 10 bit instead of a 8 bit panel. The U3011 offer a typical brightness of 370 cd/m2 and the NEC 3090WQXi of 350 cd/m2. The Color Gamut is 102% for the NEC 3090WQXi and 117% for the DELL U3011.

The new and predicate device are substantially equivalent in the areas of technical characteristics, general function, application and indented use.

| | DELL U3011 with<br>PerfectLum version 3 | Predicate device<br>NEC LCD3090WQXI<br>510(k) number: K083916 |
|-----------------------------------------------------------------|-----------------------------------------|---------------------------------------------------------------|
| Panel Type | IPS | IPS |
| Panel size | 30" viewable | 29.8" viewable |
| Native Resolution | 2560 x 1600 | 2560 x 1600 |
| Pixel Pitch | 0.25 mm | 0.25 mm |
| Brightness (typical) | 370 cd/m2 | 350 cd/m2 |
| Contrast Ratio (typical) | 1000:1 | 1000:1 |
| Viewing Angle (typical) | 178° Vert., 178° Hor. | 178° Vert., 178° Hor. |
| Displayable Colors | 1.07 billion colors | 16.7 million |
| DICOM calibration software<br>and AAPM verification<br>software | bundled | optional |

#### Comparison table

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 ·Silver Spring, MD 20993-0002

JAN 3 0 2012

Dr. Marc Leppla President and CTO QUBYX Limited 80 rue Marechal Joffre 06000 NICE FRANCE

Re: K111385

Trade/Device Name: qubyx's DELL UltraSharp U3011 with QUBYX PerfectLum Bundle Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 13, 2011 Received: December 13, 2011

Dear Dr. Leppla:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Mary S Patel

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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.K 111 385

## Indications for Use Form

510(k) Number: K111385

Device Name: qubyx's DELL UltraSharp U3011 with QUBYX PerfectLum Bundle

Indications for Use: The DELL UltraSharp U3011 with QUBYX PerfectLum is intended to be used in displaying and viewing of digital images, for review and analysis by trained medical practitioners.

The DELL UltraSharp U3011 must only be used in conjunction with QUBYX PerfectLum 3.0

These devices must not be used in primary image diagnosis in mammography.

The device can not be used for a life-support system.

Prescription Use No (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use Yes (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Slatel

Division Sign-Off Office of In Vitro Diagnostic Device

Evaluation and Safety
510(k) K111385

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