(90 days)
Not Found
Not Found
No
The summary describes a collimator, a passive component used in nuclear medicine imaging, and does not mention any software, algorithms, or processing that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is used to detect or image the distribution of radionuclides in the body, which is a diagnostic function, not a therapeutic one. It describes imaging techniques and a collimator.
Yes
The "Intended Use / Indications for Use" states "To detect or image the distribution of radionuclides in the body or organ," which is a diagnostic purpose.
No
The device description explicitly states "MULTISPECT 2 511keV Collimator," which is a hardware component used in nuclear medicine imaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "detect or image the distribution of radionuclides in the body or organ." This describes an in vivo process (within the living body), not an in vitro process (outside the body, typically on biological samples).
- Device Description: The device is a "MULTISPECT 2 511keV Collimator," which is a component used in nuclear medicine imaging equipment. This equipment is used to image the distribution of radioactive tracers administered to a patient, which is an in vivo procedure.
- Input Imaging Modality: The input modality is "Nuclear Medicine," which is an in vivo imaging technique.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device operates directly on the patient's body to capture images of radionuclide distribution.
N/A
Intended Use / Indications for Use
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s): Planar Imaging, Whole Body Imaging, Positron imaging without coincidence.
Product codes
90KPS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
All
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): 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.
Not Found
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
§ 892.1200 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
Siemens Medical Systems, Inc., Nuclear Medicine Group MULTISPECT 2 511 ke V Collimator
SUMMARY OF SAFETY AND EFFECTIVENESS June 20, 1997
| I. General Information | SEP 23 1997 |
|---|---|
| Classification Name: | System, Tomography, Computed Emission |
| Product Code: | 90KPS |
| Device Trade Name: | MULTISPECT 2 511keV Collimator |
| Classification: | Class II Medical Device |
| Intended Uses: | Anatomical Region: All |
| Diagnostic Uses: Imaging | |
| Establishment Name and Address: | Siemens Medical Systems, Inc. |
| Nuclear Medicine Group | |
| 2501 N. Barrington Road | |
| Hoffman Estates, Illinois 60195-7372 | |
| Establishment Registration Number: | Owner/Operator No. 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
The Siemens MULTISPECT 2 511keV Collimator is a product which is substantially equivalent to legally marketed devices.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Paul G. Oris Manager, Regulatory Affairs SIEMENS Medical Systems, Inc. Nuclear Medicine Group 2501 North Barrington Road Hoffman Estates, IL 60195-5203 SEP 2 3 1997
Re: K972360 Siemens MULTISPECT 2 511 keV Collimator Dated: September 4, 1997 Received: September 5, 1997 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Oris:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, 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 (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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 question 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/dsmamain.html".
Sincerely yours.
W. Hiau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (If Known): __ K 912360
Siemens MULTISPECT 2 511 Kev Collimator Option Device Name
Nuclear Medicine Device
Indications For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
| YES | NO | Energy Range (keV) | ||
|---|---|---|---|---|
| A. | Planar Imaging | X | ||
| B. | Whole Body Imaging | X | ||
| C. | Tomographic Imaging (SPECT) for non | X | ||
| Positron emitter | ||||
| D. | Positron imaging by coincidence | X | ||
| E. | Positron imaging without coincidence | X | Camera range | |
| increases to 588 keV | ||||
| F. | Other |
(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)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number
Siemens Medical Systems, Inc., Nuclear Medicine Group MS2 511 KeV Collimator 510(k) Submission
510(k) Submission Section 2 - Page 2