(14 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
No.
The intended use clearly states that it is a "diagnostic imaging device" and produces images representing "internal distribution of radioactivity in the body," not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The system is intended for use as diagnostic imaging device."
No
The device description explicitly states it is a "dual head system designed to acquire data," which implies hardware components beyond just software.
Based on the provided information, the Cardiocam system 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 outside of the body.
- Cardiocam Function: The description clearly states the Cardiocam system is a "diagnostic imaging device" that acquires data for "images produced representing the internal distribution of radioactivity in the body." This involves using radiopharmaceuticals administered to the patient and then detecting the radiation from within the patient's body.
This process is an in vivo diagnostic imaging technique, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Cardiocam system is a dual head system designed to acquire data for cardiat multi-slice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, intages are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data for high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, Tl-201, Co-57.
Product codes
90 KPS
Device Description
The Cardiocam system is a dual head system designed to acquire data for cardiat multi-slice images.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 a stylized image of an abstract human figure with three horizontal lines representing the arms and head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Danish Diagnostic Development A/S Ms. Pamela K. Gwynn Engineering Team Leader. Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 RESEARCH TRIANGLE PARK NC 27709
JUN - 8 2001
Re: K011611
Cardiocam Model 9CSY0799 Dated: May 24, 2001 Received: May 25, 2001 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Ms. Gwynn:
We have reviewed your Section 510(k) notification of intent to market the device and we 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaddsmamain.html".
Sincerely yours.
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 (s)
1
REV A01
Page
8 May 2001
I of I
ಲ್ಲಿ
B-2 FDA Indications for Use Form
Indications for Use Form
510(k) Number (if known): NOT KNOW K011611
Device Name: CARDIO CAM
Indications For Use:
The Cardiocam system is a dual head system designed to acquire data for cardiat multi-slice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, intages are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data for high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, Tl-201, Co-57.
(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)
(Division
Division
and Rad
510(k) N
K011611