(84 days)
No
The description focuses on image reconstruction through extrapolation and Fast Fourier Transformation, which are traditional signal processing techniques, not AI/ML. There is no mention of AI, ML, or related concepts like training or test sets.
No
The device is a software module for a CT operating system that extends the field of view for image reconstruction. It does not directly provide therapy or affect a patient's health outcome. Its function is limited to image processing for diagnostic purposes.
No
Explanation: The device is described as a software module that extends the field of view for image reconstruction in a CT operating system. It processes images (reconstruction) but does not provide diagnosis or contribute to diagnostic information itself. Its function is to enable a wider view for the existing CT system.
No
The device is described as a "software module within the CT operating system" and a "software package". While it is software, it is explicitly stated to be part of a CT system, which is a hardware device. The software's function is to extend the field of view for image reconstruction within that hardware system. Therefore, it is not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this software is part of a CT operating system and is used for image reconstruction from CT scans. CT scans are images of the inside of the body, not specimens taken from the body.
- The function described is image processing/reconstruction. The software extends the field of view for CT images. This is a function related to medical imaging, not laboratory testing of biological samples.
The information provided aligns with a medical imaging software component, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Extended Field of View is part of the software module within the CT operating system and provides the selection and image reconstruction variable up to a fixed limit. As an option the limit has been extended up to 70 cm and the use of this special application requires a license key.
Product codes
90 JAK
Device Description
Extended Field of View is software package, which supports the selection and image reconstruction with variable targets. The maximum of visualization has been extended to the length of 70 cm2. Due to the extrapolation of the reconstructed data and the convolution with a suitable Fast Fourier Transformation this software package allows the desired extended Field of View (FoV).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Page 1 of 2
NOV 1 0 2003
FOR THE EXTENDED FIELD OF VIEW SOFTWARE OPTION
Submitted by:
Siemens Medical Solutions, Inc. 51Valley Stream Parkway Malvern, PA 19355
August 14, 2003
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
- Contact Person: 1.
Ms. Nealie Hartman Phone: (610) 448-1769 Fax: (610) 448-1787
2. Device Name and Classification
Product Name: Common Name Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
Extended Field of View (FoV) Software Package 3D CT Reconstruction Software Accessory to Computed Tomography System Radiology 21 CFR §892.1750 Class II 90 JAK
Importer/Distributor Establishment: 3.
Registration Number: 2240869 Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355
Manufacturing Facility: 4.
Siemens AG Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany
1
KC32534
ડ. Substantial Equivalence
The Extended Field of View (FoV) software package, addressed in this premarket notification, is substantially equivalent to the following commercially available software package
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens SOMATOM Project 10 | ||
| Emotion 6 | K023687 | 11/22/02 |
| Siemens SOMATOM Project 30 | ||
| Sensation 16 | K013522 | 11/07/01 |
6. Device Description
Extended Field of View is software package, which supports the selection and image reconstruction with variable targets. The maximum of visualization has been extended to the length of 70 cm2. Due to the extrapolation of the reconstructed data and the convolution with a suitable Fast Fourier Transformation this software package allows the desired extended Field of View (FoV).
7. Intended Use
Extended Field of View is part of the software module within the CT operating system and provides the selection and image reconstruction variable up to a fixed limit.
As an option the limit has been extended up to 70 cm and the use of this special application requires a license key.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck, with three flowing lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2003
Ms. Nealie Hartman Technical Specialist Siemens Medical Systems, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K032536 Trade/Device Name: Somatom Extended Field of View Software Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II
Product Code: 90 JAK Dated: August 14, 2003 Received: August 18, 2003
Dear Ms. Hartman:
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. Iisting 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 such 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 (QS) 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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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 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
4
510(k) Number (if known): Extended Field of View Software Application Device Name:
Extended Field of View is part of the software module within the CT operating system and provides the selection and image reconstruction variable up to a fixed limit. As an option the limit has been extended up to 70 cm and the use of this special application requires a license key.
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR §801.109) OR Over-The-Counter Use
Nancy L. Bragdon
(Division Sign Off Division of Reproductive, Abdon and Radiological Devic 510(k) Number