(87 days)
No
The summary describes image registration software that matches and superimposes images, a common image processing technique. There is no mention of AI, ML, or related concepts, and the description of the technology is consistent with traditional image processing methods.
No
The device is described as software that processes and superimposes medical images for display, which aids in diagnosis rather than directly treating or preventing a disease.
Yes
Explanation: The software processes medical images (Nuclear medicine, CT, MRI) to superimpose them for display, which is a step used to aid in the detection or imaging of radionuclide distribution. While it doesn't directly make a diagnosis, it provides processed images that are used for diagnostic purposes by clinicians. Furthermore, its predicate devices are image processors. Thus, it performs diagnostic functions (e.g. image processing).
Yes
The device is described as "Automatic Image Registration Software, Model NSFU-050A" and is a "software option" for an existing medical image processor. The description focuses solely on the software's function of image processing and registration, without mentioning any new hardware components being introduced by this specific device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this software processes and superimposes medical images (Nuclear Medicine, CT, MRI) acquired from the patient's brain. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is to process and display images to detect or image the distribution of radionuclides in the body or organ. This is an in vivo imaging process, not an in vitro diagnostic process.
The device is a medical image processing software used in conjunction with a nuclear medicine image processor. While it aids in the interpretation of medical images for diagnostic purposes, it does so by processing images acquired from the patient, not by analyzing samples from the patient.
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): Tomographic Imaging (SPECT) for non Positron Emitter, Energy Range 50-400 keV.
This software is designed to be used in combination with the Toshiba GMS-5500A/UI Nuclear Medicine Medical Image Processor. The software matches the position and size of two tomographic images acquired for the brain of the same patient and superimposes them for display. Nuclear medicine, CT, and MRI images can be processed using this software. This software can be used to perform registration between images of two different modalities and superimpose them. This device employs no intended uses that are not in cleared devices already found in the marketplace.
Product codes
90 KPS
Device Description
The Automatic Image Registration Software, Model NSFU-050A is a software option for the Toshiba GMS-5500A/UI Nuclear Medical Image Processor. The software matches the position and size of two tomographic images acquired for the same patient and superimposes them for display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear medicine, CT, and MRI images
Anatomical Site
Brain
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)
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
K92992
510(k) Summary
Date: | September 3, 1999 |
---|---|
Submitter's Name: | |
Submitter's Address: | Toshiba America Medical Systems, Inc. |
P.O. Box 2068, 2441 Michelle Drive, | |
Tustin, CA 92781-2068 | |
Submitter's Contact: | Diana Thorson, Regulatory Affairs Specialist, |
(714)730-5000, Extension 4121 | |
Device Proprietary Name: | |
Classification Name: | |
Common Name: | Automatic Image Registration Software, Model NSFU-050A |
Emission Computed Tomography System | |
Gamma Camera Option | |
[Fed. Reg. No. 892.1200, Pro. Code: 90 KPS] | |
Predicate Devices: | Toshiba GMS-5500A/UI Nuclear Medicine Image Processor |
(K931297) | |
ADAC Image Fusion and Review System (K973233) | |
Reason for Submission | New option for existing product |
Description of this Device:
DEC - 3 1999
The Automatic Image Registration Software, Model NSFU-050A is a software option for the Toshiba GMS-5500A/UI Nuclear Medical Image Processor. The software matches the position and size of two tomographic images acquired for the same patient and superimposes them for display.
Summary of Intended Uses:
This software is designed to be used in combination with the Toshiba GMS-5500A/UI Nuclear Medicine Medical Image Processor. The software matches the position and size of two tomographic images acquired for the brain of the same patient and superimposes them for display. Nuclear medicine, CT, and MRI images can be processed using this software. This software can be used to perform registration between images of two different modalities and superimpose them. This device employs no intended uses that are not in cleared devices already found in the marketplace.
Technological Characteristics:
The technological characteristics of this device are the same as that of the predicate devices. Multimodality image fusion is well understood and is documented in peer reviewed scientific publications.
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 features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human figures connected by flowing lines, representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 1999
Diana Thorson Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92781-2068
Re:
K992992 Automatic Image Registration Software Model NSFU-050A Dated: September 3, 1999 Received: September 7, 1999 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Ms. Thorson:
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 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. Ilsting 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 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 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 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. 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
510 (k) Number (If Known):
992 992
Toshiba Image Registration Software, Model NSFU-050A 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 Positron Emitter | X | 50-400 | |
D. | Positron Imaging by Coincidence | |||
E. | Positron Imaging without Coincidence | X | ||
F. | Positron Whole Body Imaging by Coincidence | X |
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510 (k) Number: