(88 days)
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No
The document describes a basic DICOM image management system with standard image processing tools. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies sections.
No
The device is described as image processing software intended for viewing, quantification, manipulation, communication, printing, and management of medical images by trained medical professionals to supplement interpretation. It does not perform any direct therapeutic action or deliver therapy.
No
Explanation: While the device processes medical images from various modalities and aids clinicians in their analysis of anatomy, physiology, and pathology, its primary function is described as "image processing application software" for "viewing, quantification, manipulation, communication, printing and management of medical images." It is intended to "supplement generally accepted methods of interpreting radiological images" and specifically states that "Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations." This indicates it is not intended for primary diagnostic interpretation, but rather aids in the management and analysis of images that are then interpreted by a trained medical professional.
Yes
The device is explicitly described as "image processing application software available for installation onto customer-owned hardware," indicating it is a software-only product that runs on existing hardware.
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 perform tests on samples 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 an "image processing application software" that receives and processes "medical image data" from various imaging modalities (CT, MRI, etc.). It is used for viewing, quantification, manipulation, and management of these images.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or providing diagnostic information based on such analysis. Its function is solely focused on processing and presenting medical images.
Therefore, while it is a medical device used in a clinical setting, its function falls under the category of medical image processing and management, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
• This application 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.
• Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor whose characteristics are approved by the regulatory agency governing the market within which this application is being offered.
Product codes
LLZ, JAK, LNH
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.
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, 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
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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)
K151212, K130552, K130542, K112051, K141745, K082427, K140587, K063559
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on the second line.
October 9, 2018
Ziosoft, Inc. % Richard Ball Regulatory Consultant Ziosoft USA Inc. 1301 Shoreway Road, Suite 325 BELMONT, CA 94002
Re: K181892
Trade/Device Name: Ziostation2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ, JAK, LNH Dated: June 29, 2018 Received: July 13, 2018
Dear Richard 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
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hole 2. Nils
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181892
Device Name Ziostation2
Indications for Use (Describe)
• This application 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.
· Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor whose characteristics are approved by the regulatory agency governing the market within which this application is being offered.
| 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.
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 | |
| E-mail: | |
| Dball@ziosoftinc.com |
Intended Use
- This application 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.
- . Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor whose characteristics are approved by the regulatory agency governing the market within which this application is being offered.
Predicate Devices
Predicate devices to Ziostation2 Software Tool
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| Device Name | 510(k)
Number |
|---------------------------------------------------------------------------|------------------|
| Ziostation2 | K151212 |
| CT PULMONARY ANALYSIS | K130552 |
| SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS | K130542 |
| LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC
NAVIGATION (VBN) SOFTWARE | K112051 |
| IQQA-BODYIMAGING SOFTWARE | K141745 |
| SYNGO MR B17 | K082427 |
| MR-CT VVA | K140587 |
| ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 | K063559 |
The already-cleared Ziostation2 (K151212) 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.
Materials
This software tool consists entirely of software. No materials are contained in this product.
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 intended use of Ziostation2, no significant functional differences exist between Ziostation2 and SE K151212. Certain improvements in workflow and usability have been implemented. The function of each tool being improved or added and the difference between it and the current Ziosoft, Inc. Ziostation2 and/or predicate device are discussed in the following items.
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2) LAA analysis (Goddard)
LAA analysis (Goddard) is adding Goddard score classification to Ziostation2. The feature of Goddard score classification is legally marketed in SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS K130542. Other features are previously cleared in CT PULMONARY ANALYSIS K130552 including LAA analysis.
3) Lung Lobes
Lung Lobes is adding lung lobes extraction to Ziostation2. The feature of lung lobes extraction is legally marketed in SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS K130542. Other features are previously cleared in CT PULMONARY ANALYSIS K130552.
4) Advanced MPR Batch
Advanced MPR Batch is a workflow enhancement. No significant functional differences exist between SE K151212.
5) Virtual Bronchoscopy
Virtual Bronchoscopy is a new functionality added to Ziostation2. The feature of showing the route to the desired target and showing Virtual Bronchoscopy is legally marketed in SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS K112051 and LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE. Other features are previously cleared in SE K151212 and CT PULMONARY ANALYSIS K130552. Virtual Bronchoscopy does not communicate with real Bronchoscope.
6) CT Lung Resection Planning
CT Lung Resection Planning is a new functionality added to Ziostation2. The feature of extracting bronchi and lung lobes, extracting lesions and providing the proposal for lung resection are legally marketed in IQQA-BODYIMAGING SOFTWARE K141745 and SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS K130542. Some other lung analysis features are previously cleared in CT PULMONARY ANALYSIS K130552.
7) MR Myocardial T1 Mapping
MR Myocardial T1 Mapping is a new functionality added to Ziostation2, providing analysis of myocardium MR T1 mapping which is legally marketed in SYNGO MR B17 K082427, MR-CT VVA K140587 and ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 K063559.
MR Myocardial T1 Mapping provides post process analysis and does not provide image scanning.
8) 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.