(60 days)
Not Found
No
The summary describes standard image processing, viewing, and management functionalities without mentioning AI or ML.
No
The device is described as an "image processing workstation software package" and its intended use is to aid "trained medical imaging professionals to aid in their reading and review of such data," not to provide therapy.
Yes
The "Intended Use / Indications for Use" states that the device is intended "to aid in their reading and review of such data," which implies its use in the diagnostic process. While it's an image processing workstation, its function in viewing, quantifying, manipulating, and managing medical images directly supports the interpretation of these images by medical professionals for diagnostic purposes.
Yes
The device description explicitly states "ZIOSTATION is a software-only imaging workstation". While it integrates with standard PC hardware, the device itself is the software package.
Based on the provided text, ZIOSTATION is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body. The text clearly states that ZIOSTATION receives image data from "standard modalities (medical image scanning devices) or from image archives." This indicates it processes images generated by medical imaging equipment, not laboratory specimens.
- The intended use is for viewing, processing, and managing medical images. This aligns with the function of a medical image workstation, not a device used for in vitro testing.
- The description focuses on image processing, display, and management features. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, ZIOSTATION falls under the category of a medical image processing and management system, not an IVD.
N/A
Intended Use / Indications for Use
ZIOSTATION is an image processing workstation software package designed to run on standard PC hardware. The required hardware consists of standard 'off-the-shelf' computer components. It receives image data from standard modalities (medical image scanning devices) or from image archives. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It can be used as a just a workstation or as a client-server within a network. It is intended for use by trained medical imaging professionals to aid in their reading and review of such data.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammograpic images may only be interpreted using an FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes
LLZ
Device Description
ZIOSTATION is a software-only imaging workstation that installs on one or more of a customer's standard PCs and integrates with a customer's 'off the shelf' PC-based computer components to provide viewing, quantification, manipulation, communication, printing, and management capabilities for medical images. It provides access to both local and centralized (networked) image data.
ZIOSTATION can acquire and work with image data from multiple DICOM-compliant modalities and image archives. It provides querying and listing based on user-selected criteria. It provides for multiple types of 2D and 3D image displays. It provides interactive menus and tools for image manipulation and measurement. ZIOSTATION provides workflow enhancement and optional specialist tools for clinical applications.
ZIOSTATION uses only lossless compression for images used for diagnostic purposes. It does use lossy compression when exporting to JPEG and AVI files, but its labeling indicates that those files are not to be used for clinical evaluations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
standard modalities (medical image scanning devices) or from image archives
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical imaging professionals
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)
ZIOSTATION has been thoroughly tested by Ziosoft in accordance with their software development and validation procedures, and it has been independently evaluated by trained physicians specializing in medical imaging disciplines.
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
§ 892.2050 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
1070205
1. 510(K) SUMMARY - BASIC INFORMATION
This 510(k) Summary is prepared in accordance with 21 CFR 807.92.
1.1 SUBMITTER
MAR 2 3 2007
| Applicant: | Ziosoft, Inc.
7th Floor, TTD Building
1-2-18 Mita, Minato-ku
Tokyo, 108-0073 Japan |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Contact: | Marc Goodman, Noblitt & R |
| ﺎﺕ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ | Marc Goodman, Noonti & Rueland |
| | 5405 Alton Parkway, Suite A530 |
| | Irvine, CA 92604 |
| | USA |
Date Prepared: January 18, 2007
1.2 DEVICE NAME
| Device Name: | ZIOSTATION |
|---|---|
| Common Name: | Image processing, management and visualization system |
| Classification Name: | System, Image Processing, Radiological |
1.3 IDENTIFICATION OF LEGALLY MARKETED DEVICE
Substantial equivalence is claimed to the Barco Voxar 3D Enterprise (K061326).
1.4 DEVICE DESCRIPTION
ZIOSTATION is a software-only imaging workstation that installs on one or more of a customer's standard PCs and integrates with a customer's 'off the shelf' PC-based computer components to provide viewing, quantification, manipulation, communication, printing, and management capabilities for medical images. It provides access to both local and centralized (networked) image data.
ZIOSTATION can acquire and work with image data from multiple DICOM-compliant modalities and image archives. It provides querying and listing based on user-selected criteria. It provides for multiple types of 2D and 3D image displays. It provides interactive menus and tools for image manipulation and measurement. ZIOSTATION provides workflow enhancement and optional specialist tools for clinical applications.
ZIOSTATION uses only lossless compression for images used for diagnostic purposes. It does use lossy compression when exporting to JPEG and AVI files, but its labeling indicates that those files are not to be used for clinical evaluations.
1.5 INTENDED USE
ZIOSTATION is an image processing workstation software package designed to run on standard PC hardware. The required hardware consists of standard 'off-the-shelf' computer components. It receives image data from standard modalities (medical image scanning devices) or from image archives. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It can be
1
used as a just a workstation or as a client-server within a network. It is intended for use by trained medical imaging professionals to aid in their reading and review of such data.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammograpic images may only be interpreted using an FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by FDA.
1.6 COMPARISON TO CLEARED DEVICE
Table 1 provides a tabular comparison of ZIOSTATION features with those of the legally marketed devices identified in 1.3 above.
| Feature | ZIOSTATION | Voxar 3D Enterprise (K061326) |
|---|---|---|
| Basic Function | View, quantify, manipulate, communicate, print, and manage medical images | same |
| Computer Platform | PC with Windows OS | same |
| DICOM compliance | DICOM 3.0 | same |
| Data Acquisition | Can acquire medical image data from multiple sources including DICOM files (from image archives) and multiple DICOM-compliant modalities. | same |
| 2D Imaging | 2D image viewer with interactive controls | same |
| 3D Imaging | 3D image rendering with interactive controls | same |
| Measurement Tools | yes | yes |
| Segmentation Tools | yes | yes |
| Remote Rendering | yes | yes |
| Clinical Applications | Provides (optional) specialist tools and workflow enhancements for clinical applications such as coronary, colon, and vessel analysis. | same |
| Prescription Use | yes | same |
| Intended Users | trained professionals | same |
Table 1: Comparison of ZIOSTATION to SE Devices
2. PERFORMANCE INFORMATION
ZIOSTATION has been thoroughly tested by Ziosoft in accordance with their software development and validation procedures, and it has been independently evaluated by trained physicians specializing in medical imaging disciplines.
3. CONCLUSION
Ziosoft has demonstrated that ZIOSTATION is safe and effective for its intended use. A comparison with legally marketed devices indicates that it is substantially equivalent to those devices, and that it does not raise any new safety or efficacy concerns.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or a caduceus-like design, with flowing lines representing movement or connection.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ziosoft, Inc. c/o Mr. Marc Goodman Senior Associate Noblitt and Rueland 5405 Alton Parkway, Suite A530 IRVINE CA 92604
MAR 2 3 2007
Re: K070205
Trade/Device Name: ZIOSTATION Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 18, 2007 Received: January 22, 2007
Dear Mr. Goodman:
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 with the text "1906-2006 FDA Centennial" in the center. The letters "FDA" are large and bolded. There are three stars below the word "Centennial". The logo is surrounded by a ring of text and stars.
Protecting and Promoting Public Health
3
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.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 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.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
K070205
Indications for Use Statement
ZIOSTATION is an image processing workstation software package designed to run on standard PC hardware. The required hardware consists of standard `off-the-shelf' computer components. It receives image data from standard modalities (medical image scanning devices) or from image archives. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It can be used as a just a workstation or as a client-server within a network. It is intended for use by trained medical imaging professionals to aid in their reading and review of such data.
Lossy compressed mammographic imaqes and diqitized film screen images must not be reviewed for primary image interpretations. Mammograpic images may only be interpreted using an FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by FDA.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE TO ANOTHER PAGE IF NEEDED
| Concurrence of 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 | K070205 |