(14 days)
Not Found
No
The description focuses on traditional image processing techniques (bone mask creation, 3D registration) and does not mention AI, ML, or related concepts.
No
The device is a post-processing application for CT angiography data, facilitating diagnosis by removing bone structures from images, rather than directly treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "facilitates the diagnosis of the cerebral vasculature".
Yes
The device is described as a "dedicated post-processing application" that operates on existing CT data sets. There is no mention of hardware components being part of the device itself; it functions solely through software manipulation of medical images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: syngo Neuro DSA CT is a software application that performs post-processing on medical images (CT scans). It manipulates existing image data to improve visualization for diagnosis. It does not analyze biological samples.
Therefore, syngo Neuro DSA CT falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
syngo Neuro DSA CT is a dedicated post-processing application which allows removing bone structures from CT Angiography (CTA) data sets of the cerebral vasculature. Bone removal is based on a bone mask created from an additional non enhanced CT (NECT) scan that was three-dimensionally registered to the CTA data set. Syngo Neuro DSA CT facilitates the diagnosis of the cerebral vasculature by removing interfering bone structures from CTA data. This particularly helps to delineate aneurysms and other vascular diseases in the area of the skull base.
Product codes
90 JAK
Device Description
syngo Neuro DSA CT is a dedicated post-processing application which allows removing bone structures from CT Angiography (CTA) data sets of the cerebral vasculature. Bone removal is based on a bone mask created from an additional non enhanced CT (NECT) scan that was three-dimensionally registered to the CTA data set.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Angiography (CTA), non enhanced CT (NECT)
Anatomical Site
cerebral vasculature, skull base
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
Summary
NOV - 4 2005
K053024
Attachment 8
510(k) - Summary
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.
l. GENERAL INFORMATION
1. Device Name and Classification
Product Name: syngo Neuro DSA CT Classification Name: Accessory to Computed Tomography System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: 90 JAK
2. lmporter/Distributor Establishment: Registration Number: 2240869
Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355
3. Manufacturing Facility:
Siemens AG Medical Solutions Henkestrasse 127 D-91052 ' angen, Germany
4. Contact Person:
Mr. Rüdiger Körner Manager Regulatory Submissions Siemensstr.1; D-91301 Forchheim Phone: +49 9191 18-9355 Fax: +49 9191 18-9782
Date of Preparation of Summary: August 26th 2005 5.
510/k) submission for SIEMENC 'cunnon Nourn Don or a
1
SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL ll. EQUIVALENCE DETERMINATION
General Safety and Effectiveness Concerns 6.
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, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
7. Substantial Equivalence:
The syngo Neuro DSA CT software package that is addressed in this premarket notification, is substantially equivalent to the following commercially available software package:
| Manufacturer | Product | 510(k) | Clearance date |
|---|---|---|---|
| 1. Siemens | InSpace 4D | K043469 | 02/03/2005 |
| 2. Siemens | Leonardo | K040970 | 07/08/2004 |
Device Description and Intended Use: 8.
syngo Neuro DSA CT is a dedicated post-processing application which allows removing bone structures from CT Angiography (CTA) data sets of the cerebral vasculature. Bone removal is based on a bone mask created from an additional non enhanced CT (NECT) scan that was three-dimensionally registered to the CTA data set.
Syngo Neuro DSA CT facilitates the diagnosis of the cerebral vasculature by removing interfering bone structures from CTA data. This particularly helps to delineate aneurysms and other vascular diseases in the area of the skull base.
2
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with three stripes across its body. The eagle is facing to the right.
NOV - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens AG % Stefan Preiss Responsible Third Party Official TUV America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re.: K053024
Trade/Device Name: Syngo Neuro DSA CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 13, 2005 Received: October 21, 2005
Dear Mr. Preiss:
We have reviewed vour 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.
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 ms letter will anow you to ogin maniening of substantial equivalence of your device to a legally premarket notheation: "The I DA miding or backannal or 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 specific advice for your device on our 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, please note the regulation entition, "Ribertation on your responsibilities under the Act from the 807.97). You may obtain other general informations of the many of its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SIEMENS
Indications for use
Attachment 2
Indication for use
510(k) Number (if known):
syngo Neuro DSA CT Device Name:
syngo Neuro DSA CT is a dedicated post-processing application which allows removing bone structures from CT Angiography (CTA) data sets of the cerebral vasculature. Bone removal is based on a bone mask created from an additional non enhanced CT (NECT) scan that was three-dimensionally registered to the CTA data set.
Syngo Neuro DSA CT facilitates the diagnosis of the cerebral vasculature by removing interfering bone structures from CTA data. This particularly helps to delineate aneurysms and other vascular diseases in the area of the skull base.
(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) | ||||
| Carlyn Y Newland | ||||
| (Division Sign-Off) | ||||
| for Division of Reproductive, Abdominal, and Radiological Devices | ||||
| 510(k) Number | K053024 |