(61 days)
No
The summary describes a remote access and collaboration tool for CT image evaluation, with no mention of AI, ML, or related concepts.
No
This device is described as allowing remote access to a CT workplace for assistance with image evaluation, not for providing therapy directly.
No
The device described is an option for remote access to a CT workplace to facilitate image evaluation, not for performing diagnosis itself. Its purpose is to assist in the speed and efficiency of evaluation, but the evaluation and diagnosis are performed by human users.
Yes
The device is described as an "option" for existing Siemens CT systems and the description focuses solely on the software functionality of remote access and assistance within a LAN. There is no mention of new hardware components being introduced.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to allow remote access to a CT workplace for assistance and evaluation of images. This is a function related to image viewing and collaboration, not the analysis of biological samples or the diagnosis of disease based on in vitro tests.
- Device Description: The description focuses on remote access and collaboration for image evaluation, not on performing diagnostic tests on biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing chemical or biological reactions, or providing diagnostic information based on such analyses.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of disease. This device's function is purely related to accessing and viewing medical images.
N/A
Intended Use / Indications for Use
The syngo Expert-I option for all Siemens CT systems is intended to allow a remote access to the syngo CT workplace from clients inside the local area network.
Product codes
90 JAK
Device Description
The syngo Expert-I option allows the local user of the syngo CT workplace to get help and assistance from other personnel on the local area network (LAN) to perform an evaluation of images faster and more efficiently. For this purpose, a remote user within the LAN can log on to the syngo CT workplace.
Mentions image processing
Not Found
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
Kori449
510(K) SUMMARY FOR
JUL 25 2006
SYNGO EXPERT-I
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
May 19, 2006
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.
1. Contact Person:
Mr. Gary Johnson Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E-50 Malvern, PA 19355 Phone: (610) 448-1778 Fax: (610) 448-1787
2. Device Name and Classification
| Product Name: | syngo Expert-I |
|---|---|
| Classification Name: | Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |
3. Substantial Equivalence:
The syngo Expert-I option for all Siemens CT systems is substantially equivalent to the following medical device in commercial distribution:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| syngo Expert-I | K052423 | 01/13/2006 |
1
4. Device Description:
The syngo Expert-I option allows the local user of the syngo CT workplace to get help and assistance from other personnel on the local area network (LAN) to perform an evaluation of images faster and more efficiently. For this purpose, a remote user within the LAN can log on to the syngo CT workplace.
5. Indications for Use:
The syngo Expert-I option for all Siemens CT systems is intended to allow a remote access to the syngo CT workplace from clients inside the local area network.
6. General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 2 5 2006
Mr. Gary Johnson Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K061449
Trade/Device Name: syngo Expert-i Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 19, 2006 Received: May 25, 2006
Dear Mr. Johnson:
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, 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 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle, with the word "Centennial" underneath. There are three stars below the word "Centennial". The text around the circle is difficult to read.
Protecting and Promoting Public Health
3
Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 3 INDICATION FOR USE
510(k) Number (if known):
KU61449
Device Name:
syngo Expert-i
The syngo Expert-I option for all Siemens CT systems is intended to allow a remote access to the syngo CT workplace from clients inside the local area network.
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use R (Per 21 CFR §801.109) OR Over-The-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices