(89 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description and intended use are standard for an Emission Computed Tomography System.
No
This device is an imaging system designed to detect and image radionuclides in the body, which is a diagnostic function, not a therapeutic one.
Yes
The Intended Use states that the device is "To detect or image the distribution of radionuclides in the body or organ," which indicates its role in identifying or characterizing conditions within the body, making it a diagnostic device.
No
The device description explicitly states "Emission Computed Tomography System," which is a hardware-based imaging system. The intended use also describes detecting and imaging radionuclides, which requires physical detection hardware.
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 outside of the living body.
- Device Function: The intended use and device description clearly state that this system is used to "detect or image the distribution of radionuclides in the body or organ." This is an in vivo (within the living body) imaging technique.
- Imaging Modality: Emission Computed Tomography (ECT), including SPECT and PET (positron imaging), are imaging modalities that involve administering a radioactive tracer to a patient and then detecting the emitted radiation from within the patient's body.
Therefore, this device is an in vivo imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To detect or image the distribution of radionuclides in the body or organ, using the following techniques:
- Planar Imaging .
- . Whole body imaging
- Tomographic imaging (SPECT) for non positron emitter .
- . Positron imaging by coincidence
- . Positron imaging without coincidence up to 588 keV
Product codes
90 KPS
Device Description
E.CAM Computer, Emission Tomography System (Computer)
Mentions image processing
To detect or image the distribution of radionuclides in the body or organ
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Emission Computed Tomography System
Anatomical Site
body or organ
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
§ 892.1200 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
Summary Of Safety and Effectiveness
| Classification Name: | Emission Computed Tomography System |
|---|---|
| Classification Number: | 21 CFR 892.1200 |
| Class of Device: | II |
| Common/Usual Name: | Emission tomography system (Computer) |
| Device Trade Name: | E.CAM Computer |
Intended Use: To detect or image the distribution of radionuclides in the body or organ, using the following techniques:
- Planar Imaging ●
- . Whole body imaging
- Tomographic imaging (SPECT) for non positron emitter .
- Positron imaging by coincidence .
- Positron imaging without coincidence up to 588 keV .
| Establishment Name
and Address: | Siemens Medical Systems, Inc.
Nuclear Medicine Group
2501 North Barrington Road
Hoffman Estates, IL 60195-5203 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 1423253 (Owner/Operator 9010023) |
| Performance Standard: | None established under Section 514 of The
Food. Drug and Cosmetic Act |
II Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device.
Substantial Equivalence:
Siemens Medical Systems, Inc., Nuclear Medicine Group, believes that within the meaning of the Safe Medical Device Act of 1990 and the Medical Device Amendments of 1992 the E.CAM Computer, Emission Tomography System (Computer) is substantially equivalent to the currently marketed by Siemens Medical Systems, Inc., Nuclear Medicine Group, E.CAM (IP-500, K952109) and ICON (K903315B) and ADAC Pegasys (K892358).
Contact:
- Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. Nuclear Medicine Group 2501 North Barrington Road Hoffman Estates, IL 60195-5203 Phone: (847) 304-7516 Fax: (847) 304-7516 robert.callahan@nmg.sms.siemens.com
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, one behind the other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 1999
Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. 2501 North Barrington Road Hoffman Estates, IL 60195-5203 Re:
K992731 E.CAM Computer Dated: August 12, 1999 Received: August 13, 1999 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Callahan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have defermined 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 (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in a regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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) 594-4613. 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 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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Form
510(k) Number (if known)_K 99273/
Device Name: E.CAM Computer, Emission Tomography System (Computer)
Indication for Use: To detect or image the distribution of radionuclides in the body or organ, using the following techniques:
- Planar İmaging .
- . Whole body imaging
- Tomographic imaging (SPECT) for non positron emitter .
- . Positron imaging by coincidence
- . Positron imaging without coincidence up to 588 keV
PLEASE DO NOT WRITE BELOW THIS LINE Concurrence of the CDRH, Office of Device Evaluation (ODE)
David A. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT. and Radiological Device 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Or
Over-The-Counter Use