(20 days)
Not Found
No
The document describes a medical image viewing and management workstation with standard image processing capabilities. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is described as a workstation for viewing, diagnostic interpretation, and management of medical images. It does not treat or diagnose conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for viewing and diagnostic interpretation of images" and "intended for use as a primary diagnostic and analysis workstation."
Yes
The device description explicitly states that the software application "may be sold as a standalone product for use with 'off the shelf' PC hardware that meets minimum specifications or as a turnkey solution integrated with hardware components". This indicates that a software-only configuration is an intended and described option.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is for viewing and interpreting medical images acquired from various imaging modalities (CT, MR, etc.). It processes and displays images, not biological samples.
- The device description focuses on image and data management. It describes capabilities for accepting, transmitting, printing, displaying, storing, editing, and digitally processing medical images and associated data. This is consistent with a medical imaging workstation, not an IVD.
- There is no mention of analyzing biological samples or performing tests on bodily fluids or tissues.
Therefore, this device falls under the category of a medical imaging workstation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RA600/CA1000/Digital Hardcopy is intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US, XA and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard PC hardware. RA600 / CA1000 is intended for use as a primary diagnostic and analysis workstation in Radiology/ Cardiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.
Digital Hardcopy is intended for use primarily as a workstation for the high volume burning of CDs or DVDs containing DICOM medical images and associated diagnostic report or analysis information. CD /DVD burning and disk labeling are done via a commercially available external robotics device.
RA600/CA1000/Digital Hardcopy receives imaging studies and data over LAN, WAN, intranet or internet from a PACS server or directly from a DICOM -compliant modality or archive utilizing both lossless and lossy compression. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application. The R4600/CA1000/Digital Hardcopy workstation may interface with various information systems within the healthcare environment, such as the HIS, RIS, and CVIS. It may be sold as software only, or as a turnkey system
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy is a PC-based DICOM workstation platform which provides scaleable image and data management solutions for medical imaging. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data.
RA600/CA1000 / Digital Hardcopy may be combined with a PACS network or connected directly to a modality through the use of DICOM networking. The RA600/CA1000 / Digital Hardcopy software application may be sold as a standalone product for use with 'off the shelf' PC hardware that meets minimum specifications or as a turnkey solution integrated with hardware components to be configured to meet the users specific needs.
RA600 / CA1000 / Digital Hardcopy can also provide the hardware and OS platform for a user to operate 3rd party software and/or other GE software applications such as RIS, voice recognition, or advanced imaging analysis, and view any data presented through those applications.
RA600 / CA1000 can act as an image repository for the Centricity Web Viewer application.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, CR, DR, US, XA and other DICOM-compliant medical imaging systems
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Targeted users of this system are trained professionals, including radiologists, cardiologists, physicians, technologists and nurses.
Radiology/ Cardiology or other departments.
clinical review workstation throughout the healthcare facility
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)
The Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy complies with the voluntary standards as detailed in Section 12 Specific Standards and Guidance. The following quality assurance measures were applied to the development:
- Risk Analysis .
- . Requirements Reviews
- Design Reviews .
- . Testing on unit level (Module verification)
- . Integration testing (System verification)
- . Final acceptance testing (Validation)
- . Performance testing
- Safety testing .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K042525 Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy Workstation, K023178 Innova 4100 (Specific features), K023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis Components (Specific features)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy 510k Premarket Notification Submission
K663628
Section 2 510(k) Summary of Safety and Effectiveness
| Date: | December 19, 2006 | DEC 26 2006 |
|---|---|---|
| Submitter: | GE Healthcare Integrated IT Solutions | |
| 540 W Northwest Highway | ||
| Barrington, IL 60010 | ||
| Contact Person: | Karen M. Lunde | |
| Sr. Regulatory Affairs Leader | ||
| GE Healthcare Integrated IT Solutions | ||
| Phone: (847 277-6092 | ||
| Fax: (414) 755-0655 | ||
| Device: | ||
| Trade Name: | Centricity Radiology RA600 / Centricity Cardiology CA1000 / | |
| Centricity Digital Hardcopy | ||
| Common/Usual Name: | Picture Archiving and Communications Systems and Workstation | |
| Classification Names: | 21 CFR 892.2050 System, Image Processing, Radiological | |
| Predicate Device: | K042525 Centricity Radiology RA600 / Centricity Cardiology CA1000 / | |
| Centricity Digital Hardcopy Workstation | ||
| K023178 Innova 4100 (Specific features) | ||
| K023100 Accusketch Cardiac Quantitative System W/ Advanced | ||
| Analysis Components (Specific features) | ||
| Device Description: | Centricity Radiology RA600 / Centricity Cardiology CA1000 / | |
| Centricity Digital Hardcopy is a PC-based DICOM workstation platform | ||
| which provides scaleable image and data management solutions for | ||
| medical imaging. This software-based product provides capabilities | ||
| for the acceptance, transmission, printing, display, storage, editing | ||
| and digital processing of medical images and associated data. | ||
| RA600/CA1000 / Digital Hardcopy may be combined with a PACS | ||
| network or connected directly to a modality through the use of DICOM | ||
| networking. The RA600/CA1000 / Digital Hardcopy software | ||
| application may be sold as a standalone product for use with 'off the | ||
| shelf' PC hardware that meets minimum specifications or as a turnkey | ||
| solution integrated with hardware components to be configured to | ||
| meet the users specific needs. | ||
| RA600 / CA1000 / Digital Hardcopy can also provide the hardware and | ||
| OS platform for a user to operate 3rd party software and/or other GE | ||
| software applications such as RIS, voice recognition, or advanced | ||
| imaging analysis, and view any data presented through those | ||
| applications. | ||
| RA600 / CA1000 can act as an image repository for the Centricity Web | ||
| Viewer application. | ||
| Targeted users of this system are trained professionals, including |
Targeted users of this system are trained professionals, including radiologists, cardiologists, physicians, technologists and nurses.
1
Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy 510k Premarket Notification Submission
KUL 3628
RA600/CA1000/Digital Hardcopy is intended for viewing and Intended Use: diagnostic interpretation of images acquired from CT, MR, CR, DR, US, XA and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard PC hardware. RA600 / CA1000 is intended for use as a primary diagnostic and analysis workstation in Radiology/ Cardiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.
Digital Hardcopy is intended for use primarily as a workstation for the high volume burning of CDs or DVDs containing DICOM medical images and associated diagnostic report or analysis information. CD /DVD burning and disk labeling are done via a commercially available external robotics device.
RA600/CA1000/Digital Hardcopy receives imaging studies and data over LAN, WAN, intranet or internet from a PACS server or directly from a DICOM -compliant modality or archive utilizing both lossless and lossy compression. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application. The RA600/CA1000/Digital Hardcopy workstation may interface with various information systems within the healthcare environment, such as the HIS, RIS, and CVIS. It may be sold as software only, or as a turnkey system.
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.
- The Centricity Radiology RA600 / Centricity Cardiology CA1000 / Technology: Centricity Digital Hardcopy employs the same functional scientific technology as its predicate devices.
- Test Summary: The Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy complies with the voluntary standards as detailed in Section 12 Specific Standards and Guidance. The following quality assurance measures were applied to the development:
- Risk Analysis .
- . Requirements Reviews
- Design Reviews .
- . Testing on unit level (Module verification)
- . Integration testing (System verification)
- . Final acceptance testing (Validation)
- . Performance testing
- Safety testing .
- Conclusion: GE considers features of the Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy are equivalent to those of the predicate devices.
2
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11.00 11
Third Party Review Quality Assessment
Section 1 - Submission Information
| 510(k) No.: | K063628 |
|---|---|
| Third Party Organization: | Underwriters |
| Third Party's Primary Reviewer(s): | Silvia Ankwa |
| ODE/OIVD Division: | DRARD |
| Branch/Team: | RDB |
Section 2 - 510(k) Decision
| Third party recommendation: | SE SE NSE ____ Other (specify): ________ |
|---|---|
| ODE/OIVD final decision: | SE SE NSE ____ Other (specify): ________ |
Section 3 - Assessment of Third Party Review
| Review Element | Rating (check one) | ||
|---|---|---|---|
| Adequate | Minor Issue(s) | Major Issue(s) | |
| a. Determination of device eligibility for third party review | ✓ | ||
| b. Extent of pre-submission consultation with ODE/OIVD division | ✓ | ||
| c. Organization and format of review documentation | ✓ | ||
| d. Determination of 510(k) administrative completeness (screening review) | ✓ | ||
| e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission | ✓ | ||
| f. Comparison to legally marketed devices-identification and analysis of key similarities and differences | ✓ | ||
| g. Rationale for conclusions and recommendation | ✓ | ||
| h. Use of guidance documents and standards | ✓ | ||
| i. Resolution of 510(k) deficiencies and FDA requests for additional information | ✓ | ||
| j. Scope of reviewer expertise and use of consulting reviewers | ✓ | ||
| k. Other (specify): |
Comments (explanation of ratings/tssues):
Section 4 ODE/OIVD Assessar Information
Assessed by:
Date: 12-13-06
Tel. No.: 24
3-06 Tel. No.: 240-271-3664
Routing: Division Christompleted assessment (this page only) to inside front cover of 510(k). DMC Forward this page only to Fire Rechen, POS/ODE, Rm. 120J, Corp. Rival (HF/ 30) 1
3
Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES". The graphic in the center appears to be a stylized representation of an eagle or bird, with three curved lines forming the wings and body.
DEC 2 6 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
GE Healthcare Integrated IT Solution % Ms. Silvia Ankova Senior Project Engineer Underwriters Laboratories, Inc. 333 Pfingsten Rd. NORTHBROOK IL 60062
Re: K063628
Trade/Device Name: Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital
Hardcopy Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 5, 2006 Received: December 6, 2006
Dear Ms. Ankova:
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/11 description: The image is a black and white circular logo or seal. The text "1906-2006" is at the top of the seal. The letters "DA" are in the center of the seal in a bold, blocky font. The word "Centennial" is below the letters "DA" in a cursive font.
Protecting and Promoting Public Health
4
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I tods be actised has i Brinination that your device complies with other requirements of the Act that I Dri has made a actor regulations administered by other Federal agencies. You must or any I odolar bakated and strenging, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I at 0077, idocinig (21 CFR Part 820); and if applicable, the electronic forul in the quality by tions (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) I his letter will anow you to ough finding of substantial equivalence of your device to a legally prematicated 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 (21 cr 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/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
5
Page 1 of 1
510(k) Number (if known):
510(k) filed on October 16, 2006
Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Device Name: Hardcopy
Indications for Use:
RA600/CA1000/Digital Hardcopy is intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US, XA and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard PC hardware. RA600 / CA1000 is intended for use as a primary diagnostic and analysis workstation in Radiology/ Cardiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.
Digital Hardcopy is intended for use primarily as a workstation for the high volume burning of CDs or DVDs containing DICOM medical images and associated diagnostic report or analysis information. CD /DVD burning and disk labeling are done via a commercially available external robotics device.
RA600/CA1000/Digital Hardcopy receives imaging studies and data over LAN, WAN, intranet or internet from a PACS server or directly from a DICOM -compliant modality or archive utilizing both lossless and lossy compression. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application. The R4600/CA1000/Digital Hardcopy workstation may interface with various information systems within the healthcare environment, such as the HIS, RIS, and CVIS. It may be sold as software only, or as a turnkey system
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Barbara Bucher for NCB
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K063628