INTEGRATED REGISTRATION

K093234 · GE Medical Systems SCS · LLZ · Oct 30, 2009 · Radiology

Device Facts

• Record ID: K093234
• Device Name: INTEGRATED REGISTRATION
• Applicant: GE Medical Systems SCS
• Product Code: LLZ · Radiology
• Decision Date: Oct 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

INTEGRATED REGISTRATION permits comparison of three-dimensional (3D) images from Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Emission Tomography (PET or SPECT) and X-Ray Angiography (XA) to help physicians in diagnostic radiology or therapy planning.

Device Story

Integrated Registration is a software tool extension for GE Advantage Workstation 4.5+; functions as a multi-modality image registration and fusion application. Inputs include volumetric datasets from CT, MR, PET, SPECT, and 3D XA. Device performs 2D, 3D, and hybrid 2D/3D fusion; enables loading multiple series/modalities in a single session; provides optimized registration algorithms for modality pairs and anatomies. Output is a registered/fused image set for clinical review, saved as a DICOM Registration Object. Used by radiologists and clinicians in diagnostic or therapy planning workflows. Benefits include improved usability via automated default registration at load, manual/regional registration tools, and integration with GE Radiotherapy simulation software (Advantage Sim MD).

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical testing, including risk analysis, requirements reviews, design reviews, performance verification, and final acceptance validation.

Technological Characteristics

Software-based image registration tool running on GE Advantage Workstation 4.5+. Employs optimized registration algorithms for multi-modality image pairs (CT, MR, PET, SPECT, XA). Supports DICOM standard NEMA PS 3.1-3.18 (2008). Features include 2D/3D/hybrid fusion, automated registration at load, and manual/regional registration tools. Connectivity via DICOM networking.

Indications for Use

Indicated for physicians in diagnostic radiology or therapy planning requiring comparison of 3D volumetric images from CT, MRI, PET, SPECT, or XA modalities. No specific age or gender restrictions.

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

• Advantage Windows CT/PET Fusion (K010336)
• Advantage Windows (CT/MR) Fusion (K983256)
• Advantage Windows X-Ray/MR Fusion (K022310)

Submission Summary (Full Text)

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093234

## GE Healthcare 510(k) Premarket Notification Submission

## 510(k) Summary

OC1 3 0 2009

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | October 8th, 2009 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare, (GE Medical Systems SCS)<br>283, rue de la Minière<br>78530 Buc - FRANCE |
| Primary Contact Person: | Sophie Le Loarer<br>Regulatory Affairs Specialist<br>GE Healthcare, (GE Medical Systems SCS)<br>TEL: [phone] - FRANCE<br>FAX: [phone] - FRANCE |
| Secondary Contact Person: | Stephen G. Slavens, RAC<br>Global Regulatory Affairs Director<br>GE Healthcare, (GE Medical Systems LLC)<br>TEL: [phone]<br>FAX: [phone] |
| Device: Trade Name: | INTEGRATED REGISTRATION |
| Common/Usual Name: | INTEGRATED REGISTRATION |
| Classification Name: | 21CFR 892.2050 Picture archiving and communications system |
| Product Code: | 90LLZ |
| Predicate Devices: | K010336: Advantage Windows CT/PET Fusion<br>K983256: Advantage Windows (CT/MR) Fusion<br>K022310: Advantage Windows X-Ray/MR Fusion |
| Device Description: | The INTEGRATED REGISTRATION tool runs on Advantage<br>Workstation 4.5 or higher versions. This product is an extension<br>to the Volume Viewer application, dedicated to the registration of<br>multi-modality images, and comparison of volumetric datasets<br>from Computed Tomography (CT), Magnetic Resonance (MR),<br>Positron Emission Tomography (PET) or Single Photon Emission<br>Computed Tomography (SPECT), and 3D X-Ray Angiography<br>(XA). Note that the INTEGRATED REGISTRATION licenses<br>control which algorithms are available and which modalities can<br>be saved. |
| Intended Use: | INTEGRATED REGISTRATION permits comparison of three-<br>dimensional (3D) images from Computed Tomography (CT),<br>Magnetic Resonance Imaging (MRI), Emission Tomography<br>(PET or SPECT) and X-Ray Angiography (XA) to help<br>physicians in diagnostic radiology or therapy planning. |
| Technology: | INTEGRATED REGISTRATION consists of optimized<br>registration algorithms for pairs of modality images,<br>configuration options as licensed by the end user, and protocols<br>for use within each configuration option.<br>INTEGRATED REGISTRATION is an optimized combination<br>of its predicate devices and employs the same fundamental<br>scientific technology as these predicate devices.<br><br>Major improvements to the device include:<br>2D, 3D and hybrid 2D/3D Fusion capabilities The ability to load multiple (more than two) series and<br>multiple modalities (CT, MR, PET, SPECT, XA) in the same<br>registration session Registration results propagation to all the supported<br>modalities Optimized algorithms for modality pairs and anatomies Default registration at load Optimized tools for manual and regional registration, Reset, center and undo/redo tools to improve the usability, Protocols and layouts dedicated to typical clinical use cases, Saving ability for the new DICOM Registration Object Easier access to GE Radiotherapy simulation software:<br>Advantage Sim MD |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>INTEGRATED REGISTRATION complies with DICOM<br>Standard NEMA PS 3.1 - 3.18(2008). The following quality<br>assurance measures were applied to the development of the<br>system:<br>Risk Analysis Requirements Reviews Design Reviews Performance testing (Verification) Safety testing (Verification) Final acceptance testing (Validation)<br>Summary of Clinical Tests:<br>The subject of this premarket submission, INTEGRATED<br>REGISTRATION, did not require clinical studies to support<br>substantial equivalence. |
| Conclusion: | GE Healthcare considers the INTEGRATED REGISTRATION<br>Software application to be as safe, as effective, and performance<br>is substantially equivalent to the predicate devices. |

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510(k) Premarket Notification Submission

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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

General Electric Medical Systems SCS % Mr. Daniel W. Lehtonen Senior Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087

Re: K093234

OCT 3 0 2009

Trade/Device Name: Integrated Registration Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 14, 2009 Received: October 15, 2009

Dear Mr. Lehtonen:

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 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

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Enclosure

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine 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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GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known): K093234

Device Name: INTEGRATED REGISTRATION

Indications for Use:

INTEGRATED REGISTRATION provides easy means for comparison of three-dimensional (3D) images from Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Emission Tomography (PET or SPECT) and X-Ray Angiography (XA). To help physicians in diagnostic radiology or therapy planning, INTEGRATED REGISTRATION allows 3D registration between volumetric acquisitions that may come from the same acquisition modality or from different acquisition modalities.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Torya M. Whiz

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K093234