(88 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on data archiving and retrieval, not advanced analytical capabilities.
No
This device is for collecting, archiving, and displaying diagnostic information and images, not for treating any condition.
Yes
The "Intended Use / Indications for Use" states that the system is "intended to collect, archive, and display diagnostic information and images," directly indicating its involvement in handling diagnostic data.
No
The device description explicitly mentions "Hospital Site System" which "collects, archives, and displays diagnostic information and images" and "maintains the imaging exams and related data for local review." This suggests the presence of hardware components beyond just software for data handling and display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The CardioNow Cardiology Wide Area Archive and Retrieval System is described as a system for collecting, archiving, and displaying diagnostic information and images, specifically DICOM image data from cardiology imaging systems. It focuses on data management, storage, and retrieval.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on bodily fluids or tissues. Its function is centered around handling and displaying existing diagnostic images and data.
Therefore, while it handles diagnostic information, it does not perform the in vitro analysis that defines an IVD. It is a system for managing and accessing diagnostic imaging data.
N/A
Intended Use / Indications for Use
The CardioNow Cardiology Wide Area Archive and Retrieval System is intended to collect, archive, and display diagnostic information and images. The intent is to provide long-term archival as well as retrieval of this information to/from Hospital Site Servers and to provide compressed versions of these images to Internet Web Clients.
Product codes
90 LLZ
Device Description
The CardioNow Cardiology Wide Area Archive and Retrieval System consists of: a Hospital Site System, the Internet Data Center, Web Client, and the ClinSend Client. Each Hospital Site System collects, archives, and displays diagnostic information and images. The Hospital Site System maintains the imaging exams and related data for local review. It also formats the data for transfer to the Internet Data Center.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
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).
0
MAY 1 0 2002
CardioNow
K020449
Page 1 of 2
www.cardionow.com
535 Encinitas Boulevard Suite 118 Encinitas, CA 92024
Tel 760.633.9797 Fax 760.633.4753
9.0 510(k) Summary
Submitter
CardioNow, Inc. 535 Encinitas Boulevard Suite 118 Encinitas, CA 92024
Contact
Johnny Garza Tel: 760-633-9797 x500 Fax: 760-633-4753
Device Name
Classification: Class II
Common/usual name: Cardiology archive and review system commonly known as PACS (Picture Archiving and Communications Systems Proprietary Name: CardioNow Cardiology Wide Area Archive and Retrieval System
Intended Use
The CardioNow Cardiology Wide Area Archive and Retrieval System is intended to collect, archive, and display diagnostic information and images. The intent is to provide long-term archival as well as retrieval of this information to/from Hospital Site Servers and to provide compressed versions of these images to Internet Web Clients.
Device Description
The CardioNow Cardiology Wide Area Archive and Retrieval System consists of: a Hospital Site System, the Internet Data Center, Web Client, and the ClinSend Client. Each Hospital Site System collects, archives, and displays diagnostic information and images. The Hospital Site System maintains the imaging exams and related data for local review. It also formats the data for transfer to the Internet Data Center.
1
Image /page/1/Picture/1 description: The image shows the logo for CardioNow. The logo consists of a flower-like symbol on the left, followed by the text "CardioNow" in a bold, sans-serif font. A horizontal line is present below the text.
K020449
Page 2 of 2
Comparisons to Predicate Device
The substantially equivalent device is the Siemens ACOM.Web, also marketed as the MagicWeb Cardiac system, FDA 510k number K973131.
In reviewing the comparison between CardioNow's Wide Area Archive and Review System and the predicate device, very little difference can be found. Both systems take DICOM image data from DICOM compliant imaging systems. Both systems archive this data in the DICOM format and provide a retrieval function for review. And both systems use a lossy compression technique to provide access to these images over the Internet to users with the appropriate login and password.
The only difference is that the compression technique employed by Siemens is a lossy algorithm following the JPEG standard and the one employed by CardioNow is a lossy algorithm provided by the Apple QuickTime platform, which follows the MPEG-4 standard.
Conclusion
For the acquisition of images from DICOM compliant imaging systems and the conversion of these images using lossy compression for distribution over the Internet, the CardioNow system and the Siemens system use similar techniques and have the same functions. Thus, for DICOM compliant image distribution over the Internet, the CardioNow device is substantially equivalent to the predicate device, the Siemens ACOM.Web.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Johnny M. Garza Director, Software Quality Assurance CardioNow, Inc. 535 Encinitas Blvd., Suite 118 ENCINITAS CA 92024
MAY 1 0 2002
Re: K020449 Trade/Device Name: CardioNow Cardiology Wide Area Archive and Retrieval System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: February 4, 2002 Received: February 11, 2002
Dear Mr. Garza:
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 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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
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Page _1_of _1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K003089 KO20449
Device Name: _CardioNow Cardiology Wide Area Archive and Retrieval System Indications for Use:
The CardioNow Cardiology Wide Area Archive and Retrieval System is intended to collect, archive, and display diagnostic information and images. The intent is to provide long-term archival as well as retrieval of this information to/from Hospital Site Servers and to provide compressed versions of these images to Internet Web Clients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Posted July 1, 1998)
Prescription Use (Per 21 CFR 801.109)
Nancy Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0204
COMPANY CONFIDENTIA
February 4, 2002