(84 days)
syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
It supports the physician in diagnosis and treatment planning.
syngo Imaging XS also supports storage and archiving of Structured DICOM Reports.
In a comprehensive imaging suite syngoImaging XS integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows.
syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
Note:
Web based image distribution is not intended for reporting.
syngo Imaging XS does not support the display of mammography images for diagnosis.
syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. syngo Imaging XS also supports storage and archiving of Structured DICOM Reports. In a comprehensive imaging suite syngo Imaging XS integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo Imaging XS optionally uses a variety of advanced postprocessing applications. syngo Imaging XS (version V70) is a "software only"-system, which will be delivered on CD-ROM / DVD or also preconfigured on hardware. syngo Junasing XS will be instilled by Siemens service engineers. Defined Hardware requirements are to be met. The herewith described syngo Imaging XS supports DICOM formatted images and objects.
The provided text describes a 510(k) summary for the syngo Imaging XS (version V70) Picture Archiving and Communication System (PACS). However, it does not contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or the various study design elements requested in your prompt.
The document primarily focuses on establishing substantial equivalence to predicate devices, general device description, intended use, and regulatory classification. It mentions that "Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing." However, it does not provide details on the specific tests or their results.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.
Here's a breakdown of why the information is missing:
- Acceptance Criteria & Device Performance: The document states the device performs "as well as the predicate devices" but does not define specific metrics or criteria against which this performance is measured.
- Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone, Ground Truth Type, Training Set Size & Ground Truth: These are all elements typically found in detailed performance studies. The provided text is a regulatory summary, not a technical study report, and therefore these details are absent.
To answer your questions, I would need a different type of document, such as a detailed clinical validation report or a technical performance study report that would typically be referenced or summarized within a more comprehensive 510(k) submission, but is not present in the excerpt you provided.
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510(k) Summary
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.
I. GENERAL INFORMATION
Establishment:
.
| Address: | Siemens AG, Medical SolutionsHenkestrasse 127D-91052 ErlangenGermany |
|---|---|
| ---------- | ---------------------------------------------------------------------------------- |
- Registration Number: . 3002808157
Contact Person: Sabine Schroedel Regulatory Affairs Manager Telephone: +49 (9131) 84-2680 Telefax: +49 (9131) 84-2792
Device Name and Classification:
| Trade Name: | syngo Imaging XSVersion V70 |
|---|---|
| Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
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II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
. Device Description and Intended Use:
This premarket notification covers Siemens' enhanced PACS system syngo Imaging XS. version V70.
syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
It supports the physician in diagnosis and treatment planning. syngo Imaging XS also supports storage and archiving of Structured DICOM Reports.
In a comprehensive imaging suite syngo Imaging XS integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows.
syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
Note:
Web based image distribution is not intended for reporting.
syngo Imaging XS does not support the display of mammography images for diagnosis
syngo Imaging Workplaces
The three syngoImaging XS workplace deployments ...
- a) syngo Imaging XS Cluster Client
- syngo Imaging XS Web Client b)
- c) syngo Imaging XS Standalone Workstation
... are medical diagnostic and viewing workstations intended for postprocessing, reading, reporting, viewing and communicating / distributing of radiological softcopy images and so allow radiologists and radiological technicians to receive and process all data needed.
By usage of specific FDA approved monitors (Barco: Coronis dual head 21.3" Medical -K042221; Siemens AG: SMVD 21500 or DjSB-2103-D-5MP - K043122; Planar, Dome C5i-1 and C51-2 - K032202) diagnosis on digital mammography images is possible, but is not subported by syngo Imaging XS, as disclaimed in the Intended Use.
Integration:
The Integration of syngo Imaging XS shall be applied at different levels and by using different technologies like sharing the same HW/SW platform, using common Siemens Medical conponents (e.g. OPENLink), offering an open interface for other vendors to comrect, with other DICOM nodes and especially the DICOM Archive functionality, with other information success tems (mainly RIS).
Technological Characteristics: .
syngo Imaging XS (version V70) is a "software only"-system, which will be delivered on CD-ROM / DVD or also preconfigured on hardware. syngo Junasing XS will be instilled by Siemens service engineers.
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Defined Hardware requirements are to be met.
The herewith described syngo Imaging XS supports DICOM formatted images and objects.
General Safety and Effectiveness Concerns: .
The device labelling contains instructions for use and any necessary cautions and warning, to provide for safe and effective use of the device.
Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
. Substantial Equivalence:
The syngo Imaging XS, addressed in this premarket notification, is substantially equivalent to the following commercially available devices:
| Siemens | syngo Imaging V30 | K071114 |
|---|---|---|
| Mercury | VISAGE Pacs/CS | K072205 |
The syngo Imaging XS described in this 510(k) has the same intended use and similar technical characteristics as the device listed above in regard to the specific functionalities.
In summary, Siemens is of the opinion that syngo Imaging XS does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2008
Siemens AG, Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
Re: K082430
Trade/Device Name: syngo Imaging XS (version V70) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 28, 2008 Received: October 31, 2008
Dear Mr. Preiss:
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 (PMA), 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.
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Page 2
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 eontact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
Arque An Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number (if known): | K082430 |
|---|---|
| Device Name: | syngo Imaging XS (version V70) |
Indications For Use:
syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
It supports the physician in diagnosis and treatment planning.
syngo Imaging XS also supports storage and archiving of Structured DICOM Reports.
In a comprehensive imaging suite syngoImaging XS integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows.
syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
Note:
Web based image distribution is not intended for reporting.
syngo Imaging XS does not support the display of mammography images for diagnosis.
| Prescription Use(Part 21 CFR 801 Subpart D) | AND / OR |
|---|---|
| ------------------------------------------------- | ---------- |
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082430
510(k) for syngo® Imaging XS
§ 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).