(89 days)
90 LLZ
Not Found
No
The description focuses on 3D visualization, real-time rendering, and interactive navigation of medical images, which are standard features of advanced medical imaging workstations and do not inherently require AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is a diagnostic workstation for 3D visualization and analysis of medical images, primarily used for diagnosis and treatment planning, rather than performing therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device can be used "for diagnosis and use in treatment planning" and "diagnosing as well as treatment planning".
No
The device description explicitly states that the device "includes all the necessary hardware and software components for a medical imaging workstation". This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device processes and visualizes CT and MR images. These are images of the internal structures of the body, not specimens taken from the body.
- Intended Use: The intended uses listed are all related to the visualization, analysis, and measurement of anatomical structures within the body based on these imaging modalities.
Therefore, this device falls under the category of medical imaging software/workstation rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Realtime 3D application is intended to provide the physician with additional diagnostic information through displaying the tomographic dataset in 3 dimensional space which can show the spatial relationship among different anatomical structures. It can also be used for pre-surgical and post-surgical evaluation by surgeons. Due to its real time performance, Realtime 3D provides the user with fast case-turnaround time which leads to improved patient care and cost savings.
From user specified sets of CT or MR images, Realtime 3D can be used for
- 3D presentation of the couplete anatomic structure (i.e. head, chest, abdomen) covered by the original CT or MR images for diagnosis and use in treatment planning;
- diagnosing as well as treatment planning from real time Multi-Planar-Reconstruction (MPR):the Realtime 3D tool can help the user to position and visualize the 3-dimensional location of the MPR within the 3D volume by using interactive clip planes in real time;
- CTA and MRA displaying cohanced vessels;
- measurement of analomical structures in the 3D volume. Important for quantitative measurement of geometry and length of anatomy indices;
- displaying the position of anatomical structures in relationship to each other;
- navigating interactively through anatomical structures (e.g., vessels, colon, spine, lung, etc.) or inside the 3D volume;
- depth perception using the Stereo display option to visualize i.e. overlaying and underlying vessels:
- for viewing the inner surface of organs (vessels, colon, etc.);
Product codes
90 LLZ
Device Description
Realtime 3D (RT3D) Diagnostic Workstation includes all the necessary hardware and software components for a medical imaging workstation that allows 3D visualization of tomographic dataset from either a CT or MR scanner together with Multiplanar Reconstructions (MPR), and allows the user to fly through or around the 3D image(s) in real time. The user can also view the 3D images in stereo and make measurements in the 3D images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR scanner
Anatomical Site
head, chest, abdomen, vessels, colon, spine, lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Vitrea™ 3D Medical Visualization System, MagicView Diagnostic Workstation
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
SIEMENS
ATTACHMENT 10
510(k) Summary
Siemens Realtime 3D Software Package
NOV 10 1997
August 8, 1997
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.
General Information. I.
Establishment
.
| • Address: | Siemens Medical Systems, Inc.
186 Wood Avenue South
Iselin, NJ 08830 |
| ------------ | ---------------------------------------------------------------------------- |
|---|
| Contact Person: | Kathleen M. Rutherford
Manager, Regulatory Submissions
(908) 321-4779
(908) 321-4841 | phone
fax |
| ----------------- | ----------------------------------------------------------------------------------------------- | -------------- |
|---|
Device Name
- Trade Name: Realtime 3D Diagnostic Workstation .
- Common Name: 3D CT/MR Post-processing Workstation .
- . Classification Name: Picture Archiving and Communication System (PACS)
- Classification: Class II
- None established under Section 514 . Performance Standards: of the Food, Drug, and Cosmetic Act.
II. Information Supporting Substantial Equivalence Determination.
· Device Description:
Realtime 3D (RT3D) Diagnostic Workstation includes all the necessary hardware and software components for a medical imaging workstation that allows 3D visualization of tomographic dataset from either a CT or MR scanner together with Multiplanar Reconstructions (MPR), and allows the user to fly through or around the 3D image(s) in real time. The user can also view the 3D images in stereo and make measurements in the 3D images.
• Intended Use:
The Realtime 3D application is intended to provide the physician with additional diagnostic information through displaying the
1
SIEMENS
tomographic dataset in 3 dimensional space which can show the spatial relationship among different anatomical structures. It can also be used for pre-surgical and post-surgical evaluation by surgeons. Due to its real time performance, Realtime 3D provides the user with fast case-turnaround time which leads to improved patient care and cost savings.
· Technological Characteristics as compared to the Predicate Device:
The Realtime 3D has the same technological characteristics as Vitrea™ 3D Medical Visualization System. They both provide the user with 3D and MPR of anatomic structures. They both provide the user with a navigation tool that can be used to "Fly around" or "Fly through" the anatomy of interest. Siemens Realtime 3D offers, in addition, interactive clip planes which provides the user with real time MPR, stereo display, 3D measurement, and an orientation view during Fly-through and fly-around for better orientation and navigation.
The Realtime 3D has the same technological characteristics as the MagicView Workstation. They have substatially similar MPRs, MIPs, and volume rendering algorithm. RT3D has the added ability to show 3D images in real time.
· Substantial Equivalence:
Siemens Realtime 3D is substantially equivalent to the following devices:
- Vitrea™ 3D Medical Visualization System . Vital Images
- MagicView Diagnostic Workstation . Siemens Medical Systems, Inc.
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions Imaging Systems Group, Siemens Medical Systems
8/7/97
Date
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 10 1997
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
K973010 Realtime 3D Diagnostic Workstation Dated: August 8, 1997 Received: August 13, 1997 Regualtory class: Unclassified Procode: 90 LLZ
Dear Ms. Rutherford:
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 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, 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 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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/dsmamain.html".
Sincerely yours.
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
ATTACHMENT 1(revision)
Indications For Use
973010 510(k) Number (if known): Realtime 3D Diagnostic Workstation Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
From user specified sets of CT or MR images, Realtime 3D can be used for
- 3D presentation of the couplete anatomic structure (i.e. head, chest, abdomen) covered by the . original CT or MR images for diagnosis and use in treatment planning;
- diagnosing as well as treatment planning from real time Multi-Planar-Reconstruction (MPR):the . Realtime 3D tool can help the user to position and visualize the 3-dimensional location of the MPR within the 3D volume by using interactive clip planes in real time;
- CTA and MRA displaying cohanced vessels; .
- measurement of analomical structures in the 3D volume. Important for quantitative measurement of 9 geometry and length of anatomy indices;
- displaying the position of anatomical structures in relationship to each other; .
- navigating interactively through anatomical structures (e.g., vessels, colon, spine, lung, etc.) or . inside the 3D volume;
- depth perception using the Stereo display option to visualize i.e. overlaying and underlying vessels: .
- for viewing the inner surface of organs (vessels, colon, etc.); .
( please do no write below this line- continue on another page if needed )
Prescription Use
(Per 21 CFR 801.109)
Thind G. Seppmm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number