RTIST

K033955 · Mirada Solutions , Ltd. · LLZ · Mar 17, 2004 · Radiology

Device Facts

• Record ID: K033955
• Device Name: RTIST
• Applicant: Mirada Solutions , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Mar 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

RTist is a software application, intended to display and visualize 2D & 3D multimodality (i.e. CT, MRI, and PET) medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks at distributed locations utilizing standard PC hardware. The volume and linear measurement functions are intended for evaluation and quantification of tumor measurements, location/displacement study, analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of the region of interest (ROI), automated contouring of multi-slice ROI and labeling of 'avoidance' structure(s) during critical evaluation. Typical users of this system are trained professionals, including but not limited to radiologists, clinicians and technicians. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis.

Device Story

RTist is a standalone DICOM-compatible software application for medical image visualization and analysis. It functions as a PACS-like workstation, either as software-only or bundled with standard PC hardware. It ingests DICOM images (CT, MRI, PET), converting them into volume data for multi-planar reformatting, rendering, and measurement. Features include orthogonal slicing, zooming, panning, window/level control, and image fusion via overlays. It supports interactive and automated ROI segmentation and contouring. Used in clinical settings by radiologists and clinicians, the software facilitates quantitative evaluation of tumors and anatomical structures. Output is displayed on-screen for physician review to support clinical diagnosis and treatment planning. It enables network-based data exchange via TCP/IP.

Clinical Evidence

Bench testing only. No clinical data provided. The device relies on verification and validation of software features, including DICOM compatibility, image rendering accuracy, and measurement tool precision.

Technological Characteristics

Software-based image processing system; runs on standard off-the-shelf PC hardware. Supports DICOM 3.0 standard for data input/output. Connectivity via standard TCP/IP networks. Features include volume rendering, multi-planar reformatting, and automated/interactive segmentation algorithms. Vendor-neutral architecture.

Indications for Use

Indicated for trained professionals (radiologists, clinicians, technicians) to display, visualize, and analyze 2D/3D multimodality medical images (CT, MRI, PET) for tumor measurement, tissue evaluation, and ROI segmentation/contouring to assist in diagnosis.

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

• Cybermed v-works (K013878)
• Starpacs system (K031013)
• Viatronix V3D Explorer (K032483)
• Rex, version 3.0 (K030457)
• Plug n' view 3D (K992654)

Reference Devices

• Fusion 7D/Miraview/Reveal-MVS software platform (K020546)

Submission Summary (Full Text)

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Ko33955

| mirada | Type: Report<br>Doc.No: ms 2890-0<br>File Ref: RA<br>Title: RTist 510(k) Administrative summary | Page 2 of 4<br>Rev.Date: 16 December 2003 |
|--------|-------------------------------------------------------------------------------------------------|-------------------------------------------|
|--------|-------------------------------------------------------------------------------------------------|-------------------------------------------|

#### RTIST 510(K) SUMMARY B.

17th December, 2003 Date:

ど

MAR 1 7 2004

| Submitters Name:<br>Submitters Address:<br>Submitters Contact: | Mirada Solutions Ltd.<br>Level 1, 23-28 Hythe Bridge Street, Oxford OX1 2ET.<br>Michelle Sawyer, VP Regulatory Affairs.<br>Tel: [phone] Fax: [phone] |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitters Contact USA: | Maria Ebio; Regulatory Affairs Manager<br>CTI Molecular Imaging, Inc. 810 Innovation Drive<br>Knoxville, TN 37932<br>Phone: [phone]Fax: [phone] |
| Device Proprietary Name:<br>Common Name of Device:<br>Classification Name: | RTist<br>Multi-modality Registration Workstation Software<br>Class II: Picture Archiving and Communications System<br>(892.2050) Product Code: LLZ Image Processing System |

# Critical Definitions:

| Image Registration | The alignment of one or more [medical] images to a reference<br>image in order to facilitate geometric comparison. This is a<br>numerical operation that results in the computation of an<br>explicit mathematical transformation between every point in<br>the registered image sets. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Fusion | Registration forms the basis of image fusion in the sense that<br>the geometrical alignment of images is a prerequisite. The<br>notion of "fusion" takes this a step further by considering how<br>to visualize the content of different images representing the<br>same object [organ, anatomical region, etc.]. Such techniques<br>include the use of overlays, semi-transparent renderings, etc. |
| ROI | Region of interest. |

Note: In the context of this application, the term "registration" and "fusion" may be used interchangeably to describe geometric alignment of images and subsequent visualization.

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Page 3 of 4 Type: Report Rev. Date: 16 December 2003 ms 2890-0 Doc.No: File Ref. RA RTist 510(k) Administrative summary Title:

#### Device description:

The RTist is a software application acting as a stand alone Picture Archiving and The relise is a betting (PACS). It may be marketed as the software only as well as packaged with a standard 'off the shelf' PC Hardware. It is in effect a 'plug in' publication to the Fusion 7D/ Miraview / Reveal - MVS software platform (reference K020546) but is effectively 'vendor' neutral and as such an enhancement to many other medical image/ data management systems.

The comprehensive array of features provided by the software allows the medical professional to visualize, review, interpret, manipulate, render and distribute medical image data stored in DICOM format. The networking component of the product allows the exchange of medical image data with any other DICOM-compatible or FTPcompatible server over a standard TCP/IP network.

The RTist receives images in DICOM format, which are then converted into volume data format using core software technology. The RTist viewer provides interactive orthogonal and multi-planar reformatting which enables the user to evaluate abnormality or malformation displayed in the image. The volume and linear measurement features provided by the software enable evaluation and quantification of region of interest volume, linear measurements and location/displacement.

The software also supports interactive segmentation of the region of interest (ROI), automated contouring of multi-slice ROI and labeling of structure(s) during critical evaluation.

RTist processes an array of medical images including anatomical images (e.g. CT and conventional MRI), and functional images (e.g. SPECT and PET).

The RTist software incorporates standard visualization features to display the input DICOM data and the results of the registration operations.

#### Summary of features:

- orthogonal and any-plane slicing of the volumetric data .
- whole and region of interest zooming, .
- image panning, .
- window and level controls, .
- image overlays for which the transparcucy, threshold and color map is user . controlled.
- image interpolation �
- 2D contour .
- seed point contouring .
- 3D volume contours .

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Page 4 of 4 Report Type: Rev. Date: 16 December 2003 Doc.No: ms 2890-0 File Ref: RA RTist 510(k) Administrative summary Title:

- automated contouring of multi-slice ROI's ●
- interpreted type labeling, annotations and messaging .
- DICOM RTSS format (Standard RT Structure Set format) export .
- contour dilation .

# Intended Use:

RTist is a software application, intended to display and visualize 2D & 3D multimodality (i.e. CT, MRI, and PET) medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks at distributed locations utilizing standard PC hardware.

The volume and linear measurement functions are intended for evaluation and quantification of tumor measurements, location/displacement study, analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of the region of interest (ROI), automated contouring of multi-slice ROI and labeling of 'avoidance' structure(s) during critical evaluation.

Typical users of this system are trained professionals, including but not limited to radiologists, clinicians and technicians. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis.

| | Predicate Devices: | | |
|------------|------------------------|-------------------|-----------------------------------|
| 510(k) No. | Trade name | Manufacturer | Component Applicable to |
| K013878 | Cybermed v-works. | Cybermed Inc., | Technological<br>characteristics |
| K031013 | Starpacs system | Infintt Co., Ltd. | Data management. |
| K032483 | Viatronix V3D Explorer | Viatronix Inc. | Technological<br>characteristics. |
| K030457 | Rex, version 3.0 | Pointdx, Inc., | Technological<br>characteristics. |
| K992654 | Plug n' view 3D | Voxar Ltd. | Technological<br>characteristics. |

# Prodicato Davicas•

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 1 7 2004

Mirada Solutions Ltd % Ms. Maria Ebio Regulatory Affairs Manager CTI Molecular Imaging, Inc. 810 Innovation Drive KNOXVILLE TN 37932

Re: K033955

Trade/Device Name: RTist Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 17, 2003 Received: January 6, 2004

Dear Ms. Ebio:

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.

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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

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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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CATION FOR FOR FDA, INDICATION FOR USE FORM FOR A STATUS OF

Ver/ 3 - 4/24/96

Applicant: Mirada Solutions Ltd.

| 510(k) Number (if known): | K033955 |
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Device Name: RTist

#### Indications for Use:

RTist is a software application, intended to display and visualize 2D & 3D multimodality (i.e. CT, MRI, and PET) medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks at distributed locations utilizing standard PC hardware.

The volume and linear measurement functions are intended for evaluation and quantification of turnor measurements, location/displacement study, analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of the region of interest (ROI), automated contouring of multi-slice ROI and labeling of 'avoidance' structure(s) during critical evaluation.

Typical users of this system are trained professionals, including but not limited to radiologists, clinicians and technicians. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over - The - Counter Use Prescription Use V OR (Per 21 CFR 801.109) (Per 21 CFR 801.109) (Optional Format 1-2-96) Truthful and Accurate Statement

| I CFR 801.109) (Optional Format 1-2-96) Truthful and Accurate Stat |
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Nancy C. Brogdon

| (Division Sign-Off) | |
|--------------------------------------|---------|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K033955 |

Strictly Confidential Ltd. 2003

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