DIVA ZSP2105CMI with QUBYX PerfectLum bundle

K160328 · The Linden Group Corp · PGY · Feb 25, 2016 · Radiology

Device Facts

• Record ID: K160328
• Device Name: DIVA ZSP2105CMI with QUBYX PerfectLum bundle
• Applicant: The Linden Group Corp
• Product Code: PGY · Radiology
• Decision Date: Feb 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, including those of mammography, for review, analysis and diagnosis by trained medical practitioners. The DIVA ZSP2105CMI can be used only in conjunction with QUBYX PerfectLum. The device can not be used for a life-support system. The device does not contact with the patient. The device is intended for prescription use.

Device Story

DIVA ZSP2105CMI is a 21.3" monochrome LED-backlit LCD medical display; used in clinical settings by trained practitioners for viewing medical images (e.g., CT, X-ray, mammography). Device operates exclusively with QUBYX PerfectLum and PerfectLum Remote Management software. Software performs DICOM GSDF calibration and AAPM TG18 verification using an external X-Rite i1 Display Pro measurement device. Practitioners use the display to interpret diagnostic images; output quality ensures compliance with medical imaging standards. Benefits include accurate, standardized image visualization for clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data. Compliance with DICOM Part 14 GSDF and AAPM TG18 standards verified via testing using QUBYX PerfectLum software and X-Rite i1 Display Pro measurement device. Testing confirmed display characteristics meet target values for diagnostic medical imaging.

Technological Characteristics

21.3" monochrome IPS LCD panel; 2560 x 2048 native resolution; 0.165mm pixel pitch; 1200 cd/m2 brightness; LED backlight. Connectivity via DisplayPort. Compliant with EN60601-1, UL 60601-1, CAN/CSA C22.2 No.60601-1. Software-based calibration to DICOM GSDF and AAPM TG18 standards.

Indications for Use

Indicated for trained medical practitioners to display and view medical images, including mammography, for review, analysis, and diagnosis. Not for life-support. No patient contact.

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

• EIZO RadiForce GX540 (K151883)

Submission Summary (Full Text)

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

February 25, 2016

The Linden Group Corp. % Mr. Marc Leppla Director, CTO Oubyx Ltd. 80, rue Marechal Joffre Nice, 06000 FRANCE

Re: K160328

Trade/Device Name: DIVA ZSP2105CMI with QUBYX PerfectLum bundle Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY, Dated: January 22, 2016 Received: February 5, 2016

Dear Mr. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160328

Device Name DIVA ZSP2105CMI with QUBYX PerfectLum bundle

Indications for Use (Describe)

The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images,

including those of mammography, for review, analysis and diagnosis by trained medical practitioners.

The DIVA ZSP2105CMI can be used only in conjunction with QUBYX PerfectLum.

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

The device does not contact with the patient.

The device is intended for prescription use.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## 510(K) Summary as required by 807.92

1. Company Identification

The Linden Group Corp. 2b Wing Dr Cedar Knolls NJ 079271020 ાટ

2. Official Correspondent Mr. Marc Leppla (President and CTO of QUBYX Ltd.) Contact details: email: [e-mail] Tel: [phone]

3. Date of Submission 22/01/2016

4. Device Trade name DIVA ZSP2105CMI with QUBYX PerfectLum bundle

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

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

7. Predicate device Name: EIZO RadiForce GX540 Manufacturer: EIZO Corporation 510(k) number: K151883

## Description of the device:

The DIVA ZSP2105CMI with QUBYX PerfectLum is a 21.3" monochrome display for medical viewing. It can be used for diagnostic viewing or normal reviewing purpose of medical images like computed tomography images, digitalized x-ray images, etc. It is combined with QUBYX PerfectLum and PerfectLum Remote Management, a user-friendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM GSDF, displaying test patterns and performing acceptance and constancy tests according to AAPM TG18.

## Indications for use:

The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing of digital images, including those of mammography, for review, analysis and diagnosis by trained medical practitioners.

The DIVA ZSP2105CMI must only be used in conjunction with QUBYX PerfectLum. The device does not contact with the patient and can not be used for a life-support system. The device is intended for prescription use.

## Device comparison table:

| | Subject Device DIVA<br>ZSP2105CMI with<br>PerfectLum | Predicate device EIZO<br>RadiForce GX540 |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K160328 | K151883 |
| Panel Type | IPS | IPS |
| Panel size | 21.3" | 21.3" |
| Native Resolution | 2560 x 2048 | 2560 x 2048 |
| Pixel Pitch | 0.165mm × 0.165mm | 0.165mm × 0.165mm |
| Brightness (typical) | 1200 cd/m2 | 1200 cd/m2 |
| Viewing Angle<br>(typical) | 170° Vert., 170° Hor. | 176° Vert., 176° Hor. |
| Displayable Colors | 1024 grayscale (10-bit) | 10-bit (DisplayPort): 1,024<br>from a palette of 16,369<br>tones<br>8-bit: 256 from a palette of<br>16,369 tones |
| DICOM calibration<br>software and AAPM<br>verification software | bundled | bundled |
| Backlight | LED | LED |
| DICOM precalibrated | YES | YES |
| Power Requirements | AC 100 to 240 V,<br>50 / 60 Hz | AC 100 - 120 V,<br>200 - 240 V: 50 / 60 Hz |
| Power Consumption | 100W | 108W |
| Certification and<br>Compliance | CE (Medical Device Directive),<br>93/42/EEC, EN60601-1,<br>EN60601-2, FCC Class B,<br>cTUVus (UL 60601-1, CAN/CSA<br>C22.2 No.60601-1),<br>CNS14336-1, CNS13438),<br>VCCI by ITE, Apr.2010, Class B<br>(Requlation of VCCI V-2 and<br>VCCI-3 and VCCI V-4), RoHS,<br>WEEE | CE (Medical Device Directive),<br>EN60601-1,<br>UL60601-1, CSA C22.2 No.<br>601-1,<br>IEC60601-1,<br>VCCI-B, FCC-B, Canadian<br>ICES-003-<br>B, C-tick,<br>RoHS, China RoHS, WEEE,<br>CCC, GOST-R |
| Indications for Use | The DIVA ZSP2105CMI with<br>QUBYX PerfectLum is intended<br>to be used for displaying and<br>viewing medical images,<br>including those of<br>mammography, | The EIZO RadiForce GX540 is<br>intended<br>to be used in displaying and<br>viewing<br>digital images, including<br>standard and |
| | for review, analysis and<br>diagnosis by trained medical<br>practitioners. The DIVA<br>ZSP2105CMI can be used only<br>in conjunction with<br>QUBYX PerfectLum.<br>The device can not be used for<br>a life-support system. The<br>device does not contact with<br>the patient. | multi-frame<br>digital mammography, for<br>review,<br>analysis and diagnosis by<br>trained<br>medical practitioners. It is<br>specially<br>designed for<br>breast tomosynthesis<br>applications. |

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The comparison table shows that the subject device (DIVA ZSP2105CMI with PerfectLum) has the same intended use as the predicate one.

Although the devices have some different technological characteristics, these differences do not make the subject device less safe and reliable, so the subject device fits for diagnostic use as the predicate device does.

Both devices are compliant with DICOM Part 14 GSDF and AAPM TG18 standards, which is tested and verified by University of Arizona. To verify DICOM and AAPM compliance for the subject device, AAPM acceptance test and DICOM conformance test were also performed by QUBYX.

## Details of testing:

To verify DICOM conformance, a DICOM conformance test was performed,

using QUBYX PerfectLum software and an X-Rite i1 Display Pro measurement device. The test procedure was generated by the software in accordance with the requirements of the DICOM standard. It consisted of measurement steps, where the meter measured display's characteristics and the software recorded them. Then the software analyzed the results in comparison with target values, defined by DICOM standard, and generated the report, stating that the display is DICOM-conformant. The display device has successfully passed DICOM conformance test, so it is compliant with DICOM Part 14 GSDF standard. So is the predicate devices are substantially equivalent in this regard.

To verify AAPM TG18 conformance, an acceptance test was performed, using QUBYX PerfectLum software and an X-Rite i1 Display Pro measurement device. The test procedure was generated by the software in accordance with the requirements of the AAPM TG18 standard and consisted of measurement and visual parts.

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During the measurement steps, the meter measured display's characteristics and the software recorded them. During the visual steps, the user analyzed test patterns, generated by the software in accordance with AAPM standard. The software recorded the user's answers. Then the software analyzed the results in comparison with target values, defined by AAPM standard, and generated the report, stating that the display passes AAPM TG18 acceptance test.

The display device has successfully passed AAPM TG18 acceptance test, so it is compliant with AAPM TG18 standard and can be used as a primary category display for interpretation of medical images. The same is true for the predicate device, so the two devices are substantially equivalent in this regard.

Both devices have the same indications for use.

We can conclude that the new and predicate devices are substantially equivalent in terms of performance, indications for use, and principles of operation.