(24 days)
K 101166
No
The description focuses on standard image display, editing, measurement, storage, and transfer functionalities, with no mention of AI or ML terms or capabilities.
No
The device is described as an "Image Display of 3D/4D data sets for diagnostic purposes," and its functions are related to displaying, editing, measuring, and storing image data. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Image Display of 3D/4D data sets for diagnostic purposes".
Yes
The device is explicitly described as a "standalone Software product" and its functions are entirely software-based (display, editing, measurements, data storage, data transfer, annotations). While it processes 3D/4D data sets, it does not include any hardware components.
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 is a software product for the "Image Display of 3D/4D data sets for diagnostic purposes including measurements on displayed image." It processes and displays medical images acquired from an external source (likely an imaging modality like ultrasound, given the predicate devices).
- No mention of biological specimens: There is no indication that this device interacts with or analyzes biological specimens. Its function is solely focused on the processing and display of medical imaging data.
Therefore, based on the provided text, this device falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Image Display of 3D/4D data sets for diagnostic purposes including measurements on displayed image.
Product codes
LLZ
Device Description
4D View is a standalone Software product. which can be installed on a Laptop/PC with Microsoft Windows 7. Windows 8 and as virtual machine with Windows 7 on MAC operating systems: Primary Operating Functions are:
• Display and editing of 3D/4D data sets
• Measurements on displayed image incl. derived calculations based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology, Urology. Vascular. Neurology. Small Parts. Pediatrics. Musculo-Skeletal (Orthopedics).
• Data storage (image. measurement and patient data)
• Data transfer to and from remote systems (e.g. via DICOM)
• Adding annotations to acquired image
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal, Obstetrics, Gynecology, Cardiology, Urology. Vascular. Neurology. Small Parts. Pediatrics. Musculo-Skeletal (Orthopedics).
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
The subject of this premarket submission, 4D View, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K 101166 4D View
Reference Device(s)
K122327 GE Voluson E6/E8/E8ExpertE10 Diagnostic Ultrasound System
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).
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Image /page/0/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "K131118", which appears to be a reference or code. Below this, the text "page 1 of 2" is written in cursive, indicating that this is the first page of a two-page document. The handwriting is clear and legible, with a simple and straightforward style.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
.
MAY 1 6 2013
In accordance with 21 CFR 807.92 the following summary of information is provided:
April 19, 2013 Date:
GE Healthcare, Submitter: 9900 Innovation Dr. Wauwatosa, WI 53226
Contact Person:
Bryan Behn Regulatory Affairs Manager GE Healthcare Phone: 414-721-4214 Fax: 414-918-8275
GE Healthcare Austria GmbH & Co OG
Manufacturer:
Tiefenbach 15
Zipf. Austria 4871
Device: Trade Name: 4D View
Common/Usual Name: 4D View
Classification Names: Product Code:
Predicate Device(s):
K 101166 4D View
K122327 GE Voluson E6/E8/E8ExpertE10 Diagnostic Ultrasound System
CFR 892.2050, LLZ Picture Archiving and Communication Systems
4D View is a standalone Software product. which can be installed Device Description: on a Laptop/PC with Microsoft Windows 7. Windows 8 and as virtual machine with Windows 7 on MAC operating systems: Primary Operating Functions are:
• Display and editing of 3D/4D data sets
· Measurements on displayed image incl. derived calculations based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology,
Urology. Vascular. Neurology. Small Parts. Pediatrics. Musculo-Skeletal (Orthopedics).
· Data storage (image. measurement and patient data)
· Data transfer to and from remote systems (e.g. via DICOM)
· Adding annotations to acquired image
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Page Zoffa
GE Healthcare 510(k) Premarket Notification Submission
Image Display of 3D/4D data sets for diagnostic purposes Intended Use: including measurements on displaved image.
Summary of Non-Clinical Tests:
The 4D View employs the same fundamental scientific Technology: technology as its predicate device(s).
Modification to 4D View:
The Intended Use and Indications for use have not changed from the unmodified device. This modification introduces the ability for 4D View to work with additional GE Ultrasound features and data.
Determination of Substantial Equivalence:
The 4D View and its applications comply with voluntary standards:
-
- IEC62304. Medical device software Software life cycle processes
-
- ISO14971. Application of risk management to medical devices
-
- NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) ●
- Integration testing (System verification) .
- Performance testing (Verification)
- Safety testing (Verification)
- · Final Acceptance testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, 4D View, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the 4D View to be as safe, as effective. Conclusion: and performance is substantially equivalent to the predicate device(s).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing or feather shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2013
GE Healthcare % Mr. Bryan Behn Regulatory Affairs Manager 9900 Innovation Drive WAUWATOSA WI 53226
Re: K131118
Trade/Device Name: 4D View Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 19, 2013 Received: April 24, 2013
Dear Mr. Behn:
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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
Page 2 - Mr. Behn
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours,
Smh.7).
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are in black, contrasting with the white background.
510(k) Number (if known): K131118
Device Name: 4D View Software
Indications for Use:
Image Display of 3D/4D data sets for diagnostic purposes including measurements on displayed image.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use N/A (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) Number_
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