PHILIPS INTURIS DICOM RECORDER

K993227 · Philips Medical Systems North America, Inc. · LLZ · Dec 21, 1999 · Radiology

Device Facts

• Record ID: K993227
• Device Name: PHILIPS INTURIS DICOM RECORDER
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The PHILIPS Inturis DICOM Recorder is intended for use in recording cardio-vascular images produced in the examination room (from the INTEGRIS systems, Easy Vision 4.3 onwards or 3D workstation). on a CD-R.

Device Story

Philips Inturis DICOM Recorder is software-based image processing system; operates on PC/workstation with Windows NT 4.0 OS. Device inputs cardio-vascular images from INTEGRIS systems, Easy Vision 4.3+, or 3D workstations. Primary function is recording these images onto CD-R media for storage/archiving. Used in clinical examination rooms; operated by healthcare personnel. Output is digital image data on CD-R. Facilitates image management and archival of cardiovascular studies.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Software-based image processing system; runs on standard PC/workstation hardware; Windows NT 4.0 operating system; DICOM-compliant image recording; CD-R storage media.

Indications for Use

Indicated for recording cardio-vascular images produced in the examination room from INTEGRIS systems, Easy Vision 4.3 or later, or 3D workstations onto CD-R media.

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

• Philips CD-Medical Recorder (K945460)

Submission Summary (Full Text)

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

DEC 21 1999

Image /page/0/Picture/1 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in a simple, sans-serif font, positioned above a shield-shaped emblem. Inside the shield, there is a stylized depiction of waves and stars. The overall design is clean and minimalist, typical of corporate logos.

Image /page/0/Picture/2 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is presented in all capital letters and is horizontally oriented.

# Philips Medical Systems 510 (k) Summary

K993227

## Philips Medical Systems North America Company Company Name: Address: 710 Bridgeport Avenue Shelton, CT 06484 Peter Altman Contact Person 203-926-7031 Telephone Number: September 23, 1999 Prepared (date): Philips Inturis DICOM Recorder Device Name: Image Processing System (90 LLZ) Classification Name: Workstation Common/Usual Name Predicate Device Philips CD-Medical

### System Description:

PHILIPS Inturis DICOM Recorder is software that can be loaded on a Personal Computer or workstation with a Windows NT (4.0) Operating System.

### Intended Use:

The PHILIPS Inturis DICOM Recorder is intended for use in recording cardio-vascular images produced in the examination room (from the INTEGRIS systems, Easy Vision 4.3 onwards or 3D workstation). on a CD-R.

### Safety Information:

No new hazards are introduced by the recording of patient/image information on CD disks.

### Substantial Equivalence:

The PHILIPS Inturis DICOM Recorder is substantially equivalent to the Philips CD-Medical Recorder, K945460.

> Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-09 | 7 Tel: [phone] Fax: [phone]

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

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 caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1999

Peter Altman Director of Regulatory Affairs Philips Medical Systems, Inc. 710 Bridgeport Avenue Shelton, Connecticut 06484-0917 RE:

K993227 Philips Inturis DICOM Recorder Workstation Dated: September 23, 1999 Received: September 27, 1999 Regulatory Class: II 21 CFR 892.2050/ Procode: 90 LLZ

Dear Mr. Altman:

We have reviewed your premarket notification submission and have found this device to be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (Act). Therefore, you may immediately begin marketing this device as described in your premarket notification.

The Federal Register notice exempting your device type was published on January 21, 1998, Vol. 63, No. 13, page 3142, and was effective immediately. Therefore, manufacturers of devices falling within the above classification requlation are now exempt from the premarket notification requirements of the Act if they comply with the classification criteria. Your device's product code, classification regulation and regulatory class are shown above. When listing your device with the Food and Drug Administration, please use this product code. We suggest that you review this above referenced regulation since it may grant other exemptions from certain general controls of the Act.

In the future, new but substantially equivalent devices which fall within the above classification regulation name and meet the classification criteria may be marketed without sending a premarket notification submission to the Food and Drug Administration. We suggest, however, that you review the section entitled "Limitations on Exemptions" in the above referenced Federal Register notice to determine whether or not your new device(s) meets the exemption criteria. This Federal Register notice may be accessed on the World Wide Web at

"www.fda.gov/cdrh/modact/frclass2.html" or obtained by facsimile from the Division of Small Manufacturers Assistance's Facts On Demand at [phone] or [phone]. The order number for this notice is #394.

If you have any questions regarding this letter, please contact the Premarket Notification Staff at [phone] or the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone].

Sincerely yours,

CAPT Daniel C. Schultz, MD

CAPT Daniel G. Schultz, M Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Philips Inturis DICOM Recorder Device Name :

Indications For Use:

The PHILIPS Inturis DICOM Recorder is intended for use in recording cardio-vascular images produced in the examination room (from the INTEGRIS systems, Easy Vision 4.3 onwards, or 3D workstation), on a CD-R.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Symson

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993227

Prescription Use / ( Per 21 CFR 801.109

OR

Over-The-Counter Use

(Optional Format 1-2-96)