(20 days)
Not Found
No
The summary describes a medical image management and viewing software with standard image manipulation tools. There is no mention of AI, ML, or any features that suggest learning or adaptive capabilities.
No
The device is described as a software application for managing, archiving, and viewing medical images. Its intended uses involve image processing and manipulation for diagnostic purposes, not therapeutic treatment.
Yes
The device allows trained medical professionals to view, manipulate, perform measurements on, and post-process medical images (CT, MR, US, etc.) for diagnostic purposes, as evidenced by features like "adjustment of window width and level," "measurements," and "MPR (Multi-Planar Reformatting)," which are crucial for interpretation and diagnosis. The intended users are also listed as "trained medical professionals, including but not limited to radiologists, clinicians."
Yes
The device description explicitly states that the CDP 5000 and CDP 5000 Ensemble are "software applications." While they interact with hardware (CDs, DVDs, PCs, imaging modalities), the device itself, as described and regulated, is the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the CDP 5000 and DIAGNET are used for receiving, managing, archiving, distributing, and viewing medical images from various imaging modalities (CT, MR, etc.). These are images of the body, not specimens taken from the body.
- The tasks performed are related to image manipulation and viewing. The functions described (navigation, window/level adjustment, measurements, MPR, etc.) are typical of medical image viewers and PACS (Picture Archiving and Communication System) components. These tasks do not involve analyzing biological samples or performing diagnostic tests on bodily fluids or tissues.
The device is an image processing and management system for medical images, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The CDP 5000 is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
The CDP 5000 receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources).
Users of CDP 5000 can perform the following tasks:
- Query and retrieve images from the CDP 5000 Archive, using u any third party workstation capable of performing DICOM query/retrieve functions.
- Use DIAGNET network viewer to search, retrieve and . manipulate patient images.
- Create DICOM compliant portable media (i.e. CD-R) I containing: original DICOM images as sent by imaging modality and the DIAGNET viewer application.
Tasks that users of DIAGNET may perform include, but are not limited to: navigation; adjustment of window width and level; image stacking; measurements; inversion; zoom; magnification; rotation, Linked navigation, MPR (Multi-Planar Reformatting).
Product codes
LLZ
Device Description
The CDP 5000 is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
The CDP 5000 receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources).
Users of CDP 5000 can perform the following tasks:
- . Query and retrieve images from the CDP 5000 Archive, using any third party workstation capable of performing DICOM query/retrieve functions.
- L Use DIAGNET network viewer to search, retrieve and manipulate patient images.
- . Create DICOM compliant portable media (i.e. CD-R) containing: original DICOM images as sent by imaging modality and the DIAGNET viewer application.
Tasks that users of DIAGNET may perform include, but are not limited to: navigation; adjustment of window width and level; image stacking: measurements; inversion; zoom; magnification; rotation, Linked navigation, MPR (Multi-Planar Reformatting).
The CDP 5000 Ensemble is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The DIAGNET Viewer software, which is copied to every CD produced, runs automatically when the CD is placed in any Windows-based PC; it allows the examinee to view, manipulate, perform measurements on, and post-process the received images. The images can then be saved, copied, and/or sent to a file, emailed, or included in a report in process.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of the CDP 5000 and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist, and others.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests were performed by CDP Ltd. on the CDP 5000. In all instances, the CDP 5000 functioned as intended and the results observed were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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KC72960
Page 1 of 3
510(k) SUMMARY
CDP Ltd.'s CDP 5000
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
CDP Ltd. 23 Efal Street Kiriat Arie Petach Tikva, ISRAEL P.O. Box 3325 Zip Code 49130 Ph. +972-3-9191940 Fx. +972-3-9241023
NOV 0 8 2007
Contact Person: Doron David
Date Prepared: June 5, 2007
Name of Device and Name/Address of Sponsor
CDP 5000, Media & Distribution Center, DiagNET
23 Efal Street Kiriat Arie Petach Tikva, ISRAEL P.O. Box 3325 Zip Code 49130 Ph. +972-3-9191940 Fx. +972-3-9241023
Common or Usual Name
Picture Archiving Communications System (PACS)
Classification Name
Image Processing system Product Code LLZ -- 21 CFR 892.2050
Predicate Device
eFilm Medical Inc. eFilm Workstation with Modules, K020995, for image viewing and manipulation.
1
KC7296C
Page 2 of 3
The CDP 5000 is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
The CDP 5000 receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources).
Users of CDP 5000 can perform the following tasks:
- . Query and retrieve images from the CDP 5000 Archive, using any third party workstation capable of performing DICOM query/retrieve functions.
- L Use DIAGNET network viewer to search, retrieve and manipulate patient images.
- . Create DICOM compliant portable media (i.e. CD-R) containing: original DICOM images as sent by imaging modality and the DIAGNET viewer application.
Tasks that users of DIAGNET may perform include, but are not limited to: navigation; adjustment of window width and level; image stacking: measurements; inversion; zoom; magnification; rotation, Linked navigation, MPR (Multi-Planar Reformatting).
Typical users of the CDP 5000 and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist, and others.
Technological Characteristics and Substantial Equivalence
SUMMARY OF TECHNICAL DEVICE DESCRIPTION AND SPECIFICATIONS
The CDP 5000 Ensemble is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The DIAGNET Viewer software, which is copied to every CD produced, runs automatically when the CD is placed in any Windows-based PC; it allows the examinee to view, manipulate, perform measurements on, and post-process the received images. The images can then be saved, copied, and/or sent to a file, emailed, or included in a report in process.
The CDP 5000 is substantially equivalent to the currently marketed eFilm Medical Inc.'s eFilm Workstation with Modules, which was referenced above. The CDP 5000 and its predicate device are both picture archiving communications systems. Thus, the CDP 5000 raises no new issues of safety or effectiveness.
2
K072960
Page 3 of 3
Performance Data
Performance tests were performed by CDP Ltd. on the CDP 5000. In all instances, the CDP 5000 functioned as intended and the results observed were as expected.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus in the seal is depicted with three intertwined strands and a stylized bird-like figure at the top.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 8 2007
CPD, Ltd. % Mr. Harry van Vugt Official Correspondent KEMA Quality B.V. 4377 County Line Road CHALFONT PA 18914
Re: K072960
Trade/Device Name: CPD 5000/MEDIA & Distribution Center and Diagnet Client Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 15, 2007 Received: October 19, 2007
Dear Mr. van Vugt:
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 (PMA), 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.
4
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
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
5
Indication for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: CDP 5000/MEDIA & DISTRIBUTION CENTER and
DIAGNET CLIENT
Indication for Use:
The CDP 5000 is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
The CDP 5000 receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources).
Users of CDP 5000 can perform the following tasks:
- Query and retrieve images from the CDP 5000 Archive, using u any third party workstation capable of performing DICOM query/retrieve functions.
- Use DIAGNET network viewer to search, retrieve and . manipulate patient images.
- Create DICOM compliant portable media (i.e. CD-R) I containing: original DICOM images as sent by imaging modality and the DIAGNET viewer application.
Tasks that users of DIAGNET may perform include, but are not limited to: navigation; adjustment of window width and level; image stacking; measurements; inversion; zoom; magnification; rotation, Linked navigation, MPR (Multi-Planar Reformatting).
Typical users of the CDP 5000 and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians, technologist, and others.
20729
| Prescription Use X | Over-the-Counter Use |
|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices 11072660510(k) Number _