(88 days)
Not Found
No
The description focuses on standard image processing techniques and does not mention AI, ML, or related terms.
No
This device is an image processing application software designed for viewing, quantification, manipulation, communication, printing, and management of medical images to aid trained medical professionals in interpreting radiological images. It is not indicated for treating or preventing disease.
Yes
The device aids clinicians in their analysis of anatomy, physiology, and pathology, and is intended for use by trained medical professionals to supplement methods of interpreting radiological images. This indicates its use in identifying or confirming a diagnosis.
Yes
The device is explicitly described as "application software" and its intended use and device description focus solely on the software's functions for image processing and management. It is stated to be available for installation onto "customer-owned hardware," indicating the software is the regulated component, not the hardware it runs on.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for "viewing, quantification, manipulation, communication, printing and management of medical images" and is intended "to supplement generally accepted methods of interpreting radiological images." This describes a tool for image processing and analysis, not a test performed on biological samples to provide diagnostic information.
- Device Description: The description reinforces that it's a "basic DICOM image management system" with "various imaging tools and techniques" to process images. The added CT Dual kV capabilities are also focused on generating and manipulating images from existing scan data.
- Lack of Biological Sample Analysis: IVD devices are designed to perform tests on biological samples (blood, urine, tissue, etc.) to detect or measure substances or characteristics that provide diagnostic information. This device operates solely on medical image data.
- Focus on Image Interpretation Support: The software is intended to aid trained medical professionals in interpreting images, not to provide a diagnostic result based on a biological test.
In summary, this device is a medical image processing and management software, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
- This application software is image processing application software available for installation onto customer-owned hardware. This application software can be networked to provide for sharing of resources.
- . This application software receives medical image data (CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, and RT Image) from modalities or image archives such as PACS through network or media, and provides for the viewing, quantification, manipulation, communication, printing and management of medical images.
- This application software is intended only for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images.
Product codes
LLZ
Device Description
Ziostation2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging tools and techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, RT Image.
CT Dual kV is a new image processing tool of Ziostation2
The added capabilities provided by this additional image processing tool for use with CT DICOM compliant images are:
Generating and manipulating further images using volume data of two different tube voltage CT scans:
- O Blend image
- Subtraction image
- 0 Virtual non-contrast image
- lodine distribution map
- O 2-Material decomposition image
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, and RT Image
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical 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)
The Ziostation2 software package successfully completed integration testing/verification testing prior to validation. Regression testing was also performed on all functionality present on Ziostation2 prior to release. In addition, potential hazards have been addressed by the Ziosoft Risk Management process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K181892, K150757, K133589, K121072
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ziosoft, Inc. % Mr. Richard Ball Regulatory Consultant Ziosoft USA, Inc. 1301 Shoreway Road. Suite 325 BELMONT CA 94002
May 5, 2020
Re: K200315
Trade/Device Name: Ziostation2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: February 4, 2020 Received: February 19, 2020
Dear Mr. Ball:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200315
Device Name Ziostation2
Indications for Use (Describe)
• This application software is image processing application software available for installation onto customer-owned hardware. This application software can be networked to provide for sharing of resources.
· This application software receives medical image data (CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, and RT Image) from modalities or image archives such as PACS through network or media, and provides for the viewing, quantification, manipulation, communication, printing and management of medical images.
• This application software is intended only for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images.
Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Ziostation2 Ziosoft, Inc.
K200315 This 510(k) summary is prepared in accordance with 21 CFR 807.92.
General Information
| Trade Name | Ziostation2 |
|---|---|
| Common Name | |
| Classification Name | Picture archiving and communications system |
| System, Image Processing, Radiological (21 CFR § 892.2050 - LLZ) | |
| Applicant: | Ziosoft, Inc. |
| MitaKokusai Bldg., 1-4-28 Mita, | |
| Minato-ku, Tokyo 108-0073, Japan | |
| Contact | Richard Ball |
| Regulatory Consultant | |
| Telephone: +1 (650) 413 1300 | |
| Dball@ziosoftinc.com |
Indications for Use
- This application software is image processing application software available for installation onto customer-owned hardware. This application software can be networked to provide for sharing of resources.
- . This application software receives medical image data (CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, and RT Image) from modalities or image archives such as PACS through network or media, and provides for the viewing, quantification, manipulation, communication, printing and management of medical images.
- This application software is intended only for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images_
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Predicate Devices
Predicate devices to Ziostation2 Software Tool
| Device Name | 510(k) Number |
|---|---|
| Ziostation2 | K181892 |
| syngo.CT Dual Energy | K150757 |
| SOMATOM Force | K133589 |
| SOMATOM Definition Flash | K121072 |
The already-cleared Ziostation2 (K181892) is the primary predicate device.
Device Description
Ziostation2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging tools and techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, RT Image.
CT Dual kV is a new image processing tool of Ziostation2
The added capabilities provided by this additional image processing tool for use with CT DICOM compliant images are:
Generating and manipulating further images using volume data of two different tube voltage CT scans:
- O Blend image
- Subtraction image
- 0 Virtual non-contrast image
- lodine distribution map
- O 2-Material decomposition image
Materials
This software tool consists entirely of software. No materials are contained in this product.
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Testing Summary
The Ziostation2 software package successfully completed integration testing/verification testing prior to validation. Regression testing was also performed on all functionality present on Ziostation2 prior to release. In addition, potential hazards have been addressed by the Ziosoft Risk Management process.
Summary of Substantial Equivalence
Similarities and Differences
1) Ziostation2 with already cleared aspects
With respect to the already-cleared indications for use of Ziostation2, no significant functional differences exist between Ziostation2 and SE K181892. The function of tool added and the difference between it and the current Ziostation2 and/or predicate device are discussed in the following items.
2) CT Dual kV
CT Dual kV is a new functionality added to Ziostation2. The feature of generating and manipulating images using volume data of two different tube voltage CT scans is legally marketed in syngo.CT Dual Energy K150757, SOMATOM Force K133589 and SOMATOM Definition Flash K121072. Other features are previously cleared in SE K181892.
3) Conclusion
With respect to the tools and features offered by Ziosoft, no significant functional differences exist between Ziostation2 software and those portions of the legally marketed SE devices that perform the same functions.