DICOM THEATER

K033153 · Ferguson Medical · LLZ · Apr 23, 2004 · Radiology

Device Facts

• Record ID: K033153
• Device Name: DICOM THEATER
• Applicant: Ferguson Medical
• Product Code: LLZ · Radiology
• Decision Date: Apr 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The DICOM Theater device is intended to be used in displaying and viewing digital images for review by trained medical practitioners.

Device Story

DICOM Theater is a digital image display system designed for high-resolution visualization of medical images. It functions as a projection system for clinical review. Operated by trained medical practitioners in clinical environments, the device allows for the display and analysis of digital images to support clinical decision-making. It excludes digital mammography applications. The system provides practitioners with a visual tool to examine diagnostic data, facilitating the review process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital image display/projection system. High-resolution visualization components. Intended for medical image review. Class II device under 21 CFR 892.2050.

Indications for Use

Indicated for the display and viewing of digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

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

• Coronis 1MP Medical Flat Panel Display System (K023340)

Submission Summary (Full Text)

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## APR 2 3 2004

## 510(K) SUMMARY

K033153

| Manufacturer: | Barco NV Barcoview<br>Theodoor Sevenslaan 106<br>8500 Kortrijk<br>Belgium |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Ferguson Medical<br>Consultant to Barco NV |
| Contact Information: | Phone: [phone]<br>FAX: [phone] |
| Classification Name: | System, image processing |
| Common/Usual Name: | DICOM-compliant projection system, medical<br>projector and others |
| Proprietary Name: | DICOM Theater |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Coronis 1MP Medical Flat Panel Display System<br>(K023340) |
| Device Description: | The DICOM Theater device is a digital image<br>display system |
| Intended Use: | The DICOM Theater device is intended to be<br>used in displaying and viewing digital images<br>for review by trained medical practitioners. |
| Technological Characteristics: | The DICOM Theater consists of components to<br>provide high resolution visualization of digital<br>images. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

APR 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Barco NV Barcoview c/o Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, #931 ALBUQUERQUE NM 87111

Rc: K033153

Trade/Device Name: DICOM Theater Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: August 14, 2003 Received: January 26, 2004

Dear Mr. Ferguson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon - 10(t) prelievice is substantially equivalent (for the indications felerenced above and nave doloring and marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1770, the encordance with the provisions of the Federal Food, Drug, devices ular have occh reciasinou in assess approval of a premarket approval application (PMA). and Cosmelle Act (Act) that to not require approvisions of the general controls provisions of the Act. The 1 ou may, ulcic.org, market the act include requirements for annual registration, listing of general controls provisions of the fleet labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classifica (300 above) into exist regulations affecting your device can be it may be subject to additional controllars, 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 Please be auvised that FDA 3 issualled of a baseaan in other requirements of the Act that FDA has made a decisimilation administered by other Federal agencies. You must or ally Federal Statutes and regulations and limited to: registration and listing comply with an the Act STEquirements, invally, good manufacturing practice requirements as sch (21 CFR Part 807), labelling (21 OFF Part 820); and if applicable, the electronic forth in the quality 355tons (Q5) rog (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) This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA inding of substantial ogardevice and this, 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 If you desire spectific advice for your device on our lassing organism of
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 devices, please contact the Additionally, for questions of the pronotion and and the regulation entitled, "Misbranding
Office of Compliance at [phone]. Asso, please and tain Other general Othce of Compliance at [phone]. 7230, post 807.97) you may obtain. Other general by reference to premarket nonitation (21 or read on the Act may be obtained from the Division of Small information on your responsionities uncer assistance at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free demanain Manutacturers, International and Collsumor Pissioners and consumers of the manain.html.
[phone] or at its Internet address http://www.fda.gov/cdrh/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

Page 2

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510(k) Number (If known); K033153

Device Name: DICOM Theater

Indications For Use:

The DICOM Theater device is Intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

## Please Do Not WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use XX (Per 21 CFR 801.109)

OR

Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________

Daniel A. Lynn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 5 ( ( l ( l ( l ) Number _