(45 days)
Not Found
No
The summary describes a respiratory gating system for CT scanners that removes motion artifacts. There is no mention of AI, ML, or related terms, nor any description of training or test data sets typically associated with AI/ML development. The focus is on a technique to improve image quality by accounting for respiration, which is a common image processing technique in medical imaging and does not inherently require AI/ML.
No
The device is described as an option for CT scanners that improves image quality by removing artifacts caused by respiratory motion, leading to advancement in diagnosis. This function is focused on enhancing diagnostic imaging rather than directly treating a disease or condition. Its purpose is to assist in the diagnostic process, not to provide therapy.
No
The device is used to remove artifacts from CT scans caused by respiratory motion, which improves image quality. While this improved image quality can "advance diagnosis," the device itself is not making a diagnosis or providing diagnostic information. It is an image processing tool aimed at enhancing the clarity of images for subsequent human interpretation.
No
The device is described as an "option for CT scanners" and works "in combination with a device for Respiratory Gating," implying it is a component or feature of a larger hardware system (CT scanner and a respiratory gating device), not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states that this device is an option for CT scanners and is used to improve image quality by removing artifacts caused by respiratory motion during a CT scan. This is a process performed on the patient, not on a specimen taken from the patient.
- The intended use is related to imaging and diagnosis based on those images. The purpose is to enhance the visualization of organs or tumors by accounting for respiratory movement, which is a function of the imaging system itself.
The information provided aligns with a medical imaging device accessory or feature, not an in vitro diagnostic device.
N/A
# Intended Use / Indications for Use
The computed tomography system in combination with a device for Respiratory Gating is intended for the removal of the artifacts caused by respiratory motion. This leads to an increase of the image quality and advancement in diagnosis because the movement of organs or tumors can be visualized against the respiration phases.
Respiratory Gating is an option for CT scanners of the Sensation and the Emotion family. This application provides an improvement of the image quality by removing the artifacts caused by respiratory motion.
# Product codes (comma separated list FDA assigned to the subject device)
90 JAK
# Device Description
The computed tomography system in combination with a device for Respiratory Gating is intended for the removal of the artifacts caused by respiratory motion. This leads to an increase of the image quality and advancement in diagnosis because the movement of organs or tumors can be visualized against the respiration phases.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Computed Tomography (CT)
# Anatomical Site
Organs or tumors (implied)
# 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.
[K023687](https://510k.innolitics.com/search/K023687), [K040665](https://510k.innolitics.com/search/K040665), [K040577](https://510k.innolitics.com/search/K040577)
# 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
§ 892.1750 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
DEC 2 3 2004
K043086
page 1 of 2
510(K) SUMMARY FOR SIEMENS RESPIRATORY GATING
Submitted by:
Siemens Medical Solutions, Inc. 51Valley Stream Parkway Malvern, PA 19355
November 4, 2004
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. Debbie Peacock Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 Malvern, PA 19355 Phone: (610) 448-1773 Fax: (610) 448-1787 Email: debra.peacock@siemens.com
2. Device Name and Classification
Product Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
SOMATOM Respiratory Gating Accessory to Computed Tomography System Radiology 21 CFR §892.1750 Class II 90 JAK
3. Importer/Distributor Establishment:
Registration Number: 2240869 Siemens Medical Solutions, Inc. USA 51 Valley Stream Pkwy Malvern, PA 19355
4. Manufacturing Facility: Siemens AG Wittelsbacherplatz 2 D-80333 München, Germany
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*K043286
frye 202
5. Substantial Equivalence
Option, addressed in this premarket notification, is The Respiratory Gating substantially equivalent to the following commercially available software package:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens SOMATOM Project P10F | K023687 | 11/22/2002 |
| Siemens SOMATOM Project 30F | K040665 | 04/02/2004 |
| Siemens SOMATOM Project 30L | K040577 | 03/22/2004 |
6. Device Description
The computed tomography system in combination with a device for Respiratory Gating is intended for the removal of the artifacts caused by respiratory motion. This leads to an increase of the image quality and advancement in diagnosis because the movement of organs or tumors can be visualized against the respiration phases.
7. Indications for Use
Respiratory Gating is an option for CT scanners of the Sensation and the Emotion family. This application provides an improvement of the image quality by removing the artifacts caused by respiratory motion.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2004
Ms. Debbie Peacock Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 MALVERN PA 19355
Re: K043086 Trade/Device Name: Somatom Respiratory Gating Regulation Number: 21 CFR 872.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: November 4, 2004 Received: November 8, 2004
Dear Ms. Peacock:
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 rear 20, 1110, 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 do not require approvisions of the Act. The general controls provisions of the Act include reguirements 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 (Special Controls) or class III (Premarket n your a rise is the 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) I mis letter will anow you to ough finding of substantial equivalence of your device to a legally premaired notification: "The PDF Intentig sification 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 If you desire specifice of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 607.97). " Od may obtain outer gineer ational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.ggv/cdrh/dsmadsmamain.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
Indications for Use
KU43086 510(k) Number (if known): Respiratory Gating Device Name:
Respiratory Gating is an option for CT scanner of the Sensation and the Emotion family. This application provides an improvement of the image quality by removing the artifacts caused by respiratory motion.
(Please do not write below this line - continue on another page if needed)
\
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter Use
(Per 21 CFR §801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number the markdown is not generated correctly. Please check the markdown and try again. The markdown should be as faithful to the original image as possible. Do not omit any text present in the image. The formatting should be in markdown, with the rules provided in the context. The markdown should be a string. The string should be a valid JSON string. The JSON string should be an array of JSON objects. Each JSON object should have a key called
000016