IMCO-STAT

K063392 · Imco Technologies · LLZ · Dec 12, 2006 · Radiology

Device Facts

• Record ID: K063392
• Device Name: IMCO-STAT
• Applicant: Imco Technologies
• Product Code: LLZ · Radiology
• Decision Date: Dec 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

IMCO-STAT™ is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STAT™ server in DICOM 3.0 Part 10 and JPEG format. IMCO-STAT™ is designed to send reports, images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments. This is accomplished using an executable client application on a receiving entity with the appropriate hardware. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Story

IMCO-STAT™ is a software-based image management system receiving DICOM 3.0 inputs from medical imaging equipment. It stores data in DICOM Part 10 and JPEG formats on a server. The system transmits reports, images, audio, and video to client workstations, PDAs, or Tablet PCs via wired or wireless networks. It provides tools for image viewing, including annotation, measurement, cine loops, comparison modes, and window/level control. Designed for use by healthcare professionals inside and outside radiology departments. The output allows clinicians to review patient studies remotely or at the point of care, facilitating clinical decision-making through access to diagnostic images on mobile or standard hardware. It benefits patients by enabling faster access to imaging data for clinical review.

Clinical Evidence

No clinical data. Bench testing only. Validation performed by programmers, non-programmers, quality control personnel, and potential customers to verify software functionality and hardware integration.

Technological Characteristics

Software-based PACS/image processing system. Operates on standard off-the-shelf Windows-based hardware. Inputs: DICOM 3.0. Outputs: JPEG/Wavelet compressed images. Connectivity: TCP/IP, wired/wireless. Features: Annotation, measurement, cine, comparison mode, window/level control. Supports mobile devices (PDA, Tablet PC).

Indications for Use

Indicated for clinical review of digital medical images and data received from imaging equipment via DICOM 3.0. Supports transmission to workstations, PDAs, and Tablet PCs. Contraindicated for primary interpretation of lossy compressed mammographic images or digitized film screen images; mammographic interpretation requires FDA-approved 5 Mpixel resolution monitors.

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

• Medical Insight EasyViz system (K051809)
• Marotech, Inc. Marosis PACS System (K012844)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a logo for IMCO Technologies. The logo features the letters "IMCO" in a bold, sans-serif font, with the letters arranged horizontally. The word "TECHNOLOGIES" is written in a smaller font below the letters "IMCO". The letters are in a dark color, and the background is white.

DEC 1 2 2006

The Image Management Company

510(k) Summary

In accordance with the provisions of the Safe Medical Device Act of 1990. IMCO Technologies is providing a summary of safety and effectiveness information regarding the IMCO-STAT™ software

- 1 1 Company Identification
IMCO Technologies N27W23957 Paul Road Pewaukee WI 53072 Contact. Mark Schwartz, President and CEO Telephone, 262-523-4445 Fax: [phone] Email: [e-mail]

- 1.2 Official Correspondent
Mark Schwartz. President and CEO IMCO Technologies N27W23927 Paul Rd Pewaukee WI 53072 Telephone: [phone] Fax: [phone] Email: [e-mail]

- 1.3 Date of Submission
November 7, 2006

- 1 4 Device Name
Classification Name Common/Usual Name Proprietary Name:

System. Image Processing, Radiological Soft-copy reading system IMCO-STAT TH

- 1.5 Substantial Equivalence
The IMCO-STAT™ system has the same intended uses and technical characteristics as the Medical Insight EasyViz system (K051809) and Marotech, Inc. Marosis PACS System (K012844).

IMCO Technologies 510(k) Summary Page | 01 |

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| Product Name | IMCO Stat | Medical<br>Insight<br>EasyViz | Marosis<br>PACS |
|-----------------------------------------------|-----------|-------------------------------|-----------------|
| Graphical UI | Yes | Yes | Yes |
| Windows O.S. - Client | Yes | Yes | Yes |
| Uses Standard Monitor | Yes | Yes | Yes |
| Scales Image to Display | Yes | Yes | Yes |
| Image Input | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| Images stored on remote Window server | Yes | Yes | Yes |
| Network Protocol | TCP-IP | TCP-IP | TCP-IP |
| Compression | JPEG 2K | Proprietary | JPEG 2K |
| Wireless Capability | Yes | Yes | No |
| Support Tablet PC, PDA, etc | Yes | Yes | No |
| Annotation | Yes | Yes | Yes |
| Image Measurement | Yes | Yes | Yes |
| Cine tool | Yes | Yes | Yes |
| Comparison Mode | Yes | Yes | Yes |
| Review Report from RIS | No | Yes | Yes |
| Designed for Use Inside and Outside Radiology | Yes | Yes | Yes |
| Flip / Rotate of Images | Yes | Yes | Yes |
| User Log In | Yes | Yes | Yes |
| Multiple Layout Options | Yes | Yes | Yes |
| WWL control & Pre-sets | Yes | Yes | Yes |
| Patient & Study Browser | Yes | Yes | Yes |
| Print to Paper Capability | No | Yes | Yes |

## 1.6

## Device Description and Intended Use

IMCO-STAT™ is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STAT™ server in DICOM 3 0 Part 10 and JPEG format.

IMCO-STAT™ is designed to send reports, images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments. This is accomplished using an executable client application on a receiving entity with the appropriate hardware.

The images may be embedded for reference in a DICOM image comprised report data, for distribution across a network and storage in a Picture Archive Communication System (PACS) with the original exam series data. Wavelet files can also be created and stored utilizing the same process. The algorithms used to create JPEG and wavelet images follow known and accepted protocols.

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IMCO-STAT™ uses standard off-the-shelf hardware and commercially available IMOO-07/11-1650 and operating systems. The software communicates using computer plationne and operthe network used to support the TCP/IP stack is superfluous to IMCO-STAT™

## General Safety and Effectiveness Concerns. 1 . ?

The device labeling contains instructions for use and indications for use. The The "device" laboling" components specified are off-the-shelf computer components

Validation and Effectiveness:

Testing of the software and related hardware has been performed by programmers, non-programmers, quality control individuals and potential customers

Lossy compressed mammographic images and digitized film screen images must Eosby comproboa nor primary image interpretations. Mammographic images may not be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Substantial Equivalence

As stated previously, IMCO-STAT™ is substantially equivalent to EasyViz software package and Marosis PACS.

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Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Mark L. Schwartz President / CEO IMCO Technologies N27W23957 Paul Road #101 PEWAUKEE WI 53072

DEC 1 2 2006

Re: K063392

Trade/Device Name: IMCO-STATTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 7, 2006 Received: November 9, 2006

Dear Mr. Schwartz:

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 (Premarket Approval), 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.

Image /page/3/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in large, bold font in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial".

Protecting and Promoting Public Health

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

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely yours.

Nancy C. Hogdon

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

Enclosure

Page 2 -

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Image /page/5/Picture/0 description: The image shows a logo with the text "IMCO" in a stylized font. The top half of the letters "MC" are black, while the rest of the letters are in a lighter shade. Below the logo, the word "TECHNOLOGIES" is written in a simple, sans-serif font.

The Image Management Company

## INDICATIONS FOR USE

KOL 3392 510(k) Number (if known):

IMCO-STATTM Device Name:

IMCO Technologies Sponsor Name:

Indications for Use:

IMCO-STATTM is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STATTM server in DICOM 3.0 Part 10 and JPEG format.

IMCO-STAT™ is designed to send reports. images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments. This is accomplished using an executable client application on a receiving entity with the appropriate hardware.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Prescription Use (21 CFR 801 Subpart D) And/Or

Over-The-Counter Use | | (21 CFR 807 Subpart C)

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation

David ln Ingram

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

IMCO Technologies N27 W23957 Paul Road, Pewaukee, WI 53072 PH: 800/300-7734 262/523-4445 FX: 262/523-1141

www.imco-tech.com