(85 days)
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.
PHILIPS Inturis DICOM Recorder is software that can be loaded on a Personal Computer or workstation with a Windows NT (4.0) Operating System.
The provided text is a 510(k) summary for the Philips Inturis DICOM Recorder. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria, detailed performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.
Therefore, I cannot provide the requested information from the given text. The document is primarily focused on regulatory submission and demonstrating substantial equivalence rather than reporting on technical performance studies with specific statistical metrics.
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DEC 21 1999
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Philips Medical Systems 510 (k) Summary
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: (203) 926-7674 Fax: (203) 929-6099
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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 (800) 899-0381 or (301) 827-0111. The order number for this notice is #394.
If you have any questions regarding this letter, please contact the Premarket Notification Staff at (301) 594-1190 or the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597.
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
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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)
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).