SEEMOR 5.0 IMAGE DISPLAY PROGRAM

K041782 · Areeda Assoc., Ltd. · LLZ · Aug 16, 2004 · Radiology

Device Facts

• Record ID: K041782
• Device Name: SEEMOR 5.0 IMAGE DISPLAY PROGRAM
• Applicant: Areeda Assoc., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

SeeMor™ 5.0 software program should be used for the transfer, display and image manipulation of multimodality diagnostic medical images and for the image reconstruction of SPECT & PET gated and ungated myocardial perfusion data.

Device Story

SeeMor™ 5.0 is a medical imaging software application for personal computers (Windows/Macintosh) used by physicians for the transfer, viewing, and interpretation of diagnostic images. The ReconTool™ module enables reorientation and tomographic reconstruction of SPECT and PET gated and ungated myocardial perfusion datasets. The software provides various manipulation tools including window/level adjustment, magnification, pan, cine, and orthogonal view reconstruction. The device serves as a display and processing aid; it does not provide automated diagnostic interpretation. The physician retains final responsibility for clinical interpretation. The software is intended for use in clinical settings to assist in the diagnostic process by providing enhanced visualization and reconstruction of perfusion data.

Clinical Evidence

Bench testing only. Effectiveness was established through an in-house trial validation involving an evaluation of 20 patient datasets to confirm the software's ability to perform image reconstruction and display functions.

Technological Characteristics

Software-based medical imaging application; executes on non-proprietary hardware (Windows PC or Macintosh). Functions include image manipulation (clipping, window/level, magnification, cine) and tomographic reconstruction of SPECT/PET data. Connectivity via standard PC interfaces. No specific materials or energy sources; software-only device.

Indications for Use

Indicated for the transfer, display, and manipulation of multimodality diagnostic medical images and for the reconstruction of SPECT and PET gated and ungated myocardial perfusion data in patients undergoing such diagnostic imaging.

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

• AutoSPECT Plus (K992317)

Submission Summary (Full Text)

{0}------------------------------------------------

K041132

AUG 1 6 2004

# ITEM I

# 510(k) SUMMARY

## Safety and Effectiveness

## 1. Medical Device Establishment:

Areeda Associates Ltd Registration No. 2030898 Owner Operator I.D. 9029223 Device Regulation Number: 892.1200 Product Code: 90 LLZ Classification Panel: Radiology Voice: [phone], FAX: [phone] Contact Person: Joseph Areeda or Kenneth Van Train Areeda Associates, Ltd. Address: 516 N. Curson Avenue Los Angeles, CA 90036 Date Summary Prepared: May 17, 2004

#### 2. Medical Device:

SeeMor™ 5.0 - Medical Imaging Display & Processing program executing on personal computer systems with ReconTool™ .

#### 3. Medical Device Equivalence:

AutoSPECT Plus developed by ADAC Laboratories Ref. 510(k) #: K992317.

#### 4. Device Description:

The SeeMor™ 5.0 medical viewing application is used for transfer and viewing diagnostic medical images. The program provides the capabilities of manipulating the images being displayed with the command options including: clipping, window/level adjustment, magnification, pan, relate, add, delete, next, cine, lock, select, view, flip vertical/horizontal, set color table, orthogonal view reconstruction, cascade, tile, and reset. The ReconTool™ processing application within Seemor™ 5.0 can be used to reorient and apply tomographic reconstruction to SPECT & PET gated and ungated myocardial perfusion image data sets.

5. Intended Use and Potential Adverse Effect on Health:

{1}------------------------------------------------

The intended use of this program was to provide the physician with a display program which would allow for the transfer, remote viewing and interpretation of medical images. In whilen would and optional feature has been added to allow for the reorientation and addition, "of "Optional" T& PET gated and ungated myocardial perfusion image data sets. This program serves merely as a display program to aid in the diagnostic interpretation of a This program sorves morory as a display provide reconstruction capability of SPECT & PET patients Study and to provide roomantic interpretive output other than the display of the images. It does not provide any magins no direct adverse effect on health since it is only wroviding a means of displaying the medical images for the physician. The final responsibility for interpretation of the study lies with the physician.

## 6. Marketing History:

There have been multiple medical device programs marketed in the past which perform similar functions to those performed by SeeMor™ with the ReconTool™ . These programs are all used for the purpose of reorienting and reconstruction of SPECT & PET myocardial perfusion image data sets. The SeeMor™ 5.0 program with ReconTool™ provides a program which executes on non-propriety hardware (such as Windows PC or Macintosh) and we believe is substantially equivalent to the (outoration) Plus developed by ADAC Laboratories K992317. To our knowledge there have been no safety problems with the AutoSPECT Plus medical display program which has been in the marketplace for over four years.

## 7. Conclusions:

The safety of this program has been determined through the various stages of software development which included the initial design, coding, debugging, testing, and in house validation. The effectiveness of the program has been established in an in-house trial validation which included an evaluation of 20 patients. We contend that the method employed for the development and the final in-house trial validation results of the SeeMor™ medical software program (with ReconTool™) have proven its safety and effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings or feathers. The symbol is black, and the text is also in black.

Food and Drug Administrati 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 6 2004

Re: K041782

Mr. Joseph Areeda President Areeda Associates Ltd. 516 N. Curson Ave. LOS ANGELES CA 90036-1814

Trade/Device Name: SeeMor™ Image Display Program Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ and KPS Dated: June 15, 2004 Received: July 1, 2004

Dear Mr. Arceda:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beceible of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) vo vogo J
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to ooniner of the 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). and Cosmetic (110) that be nevice, subject to the general controls provisions of the Act. The r ou may, therefere, misions 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 may or subject to satin additions, 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 I toase be determination that your device complies with other requirements of the Act that I DT has made a vegulations administered by other Federal agencies. You must comply or uny I occareer and managements, 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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter with and in you to substantial equivalence of your device of your device to a legally promative notification: "The 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. Brydon

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

Enclosure

Page 2

{4}------------------------------------------------

510(k) NUMBER (IF KNOWN): K041782

DEVICE NAME: SeeMor™ 5.0 Image Display Program

INDICATION FOR USE:

SeeMor™ 5.0 software program should be used for the transfer, display and image manipulation of multimodality diagnostic medical images and for the image than backprojection reconstruction reconstruction of SPECT & PET gated and ungated myocardial perfusion data.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR Over-the-Counter Use

(Optional Format 1-2-96)

Nancy broglon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041782