(150 days)
Not Found
No
The document describes a system for capturing, storing, and managing medical images (DICOM). While it mentions "processing" images, there is no mention of AI, ML, deep learning, or any related terms or concepts that would indicate the use of such technologies for image analysis, interpretation, or other AI/ML-driven functions. The focus is on data management and communication.
No.
The device is described as an image management system that captures, stores, communicates, processes, and displays medical images and data, without any mention of providing therapy or direct treatment to patients.
No
The device is described as an image management system that captures, stores, communicates, processes, and displays medical images and data. It does not perform a diagnostic function itself, but rather manages data that may be used for diagnosis by trained professionals.
Yes
The device description explicitly states it consists of three modules: a DICOM Gateway, Image Manager Server, and Image Manager Client. These are software components that handle image capture, storage, communication, processing, and display. While it interacts with hardware imaging sources, the device itself, as described, is the software system managing these functions.
Based on the provided information, the CSIST DICOM Gateway and Image Manager™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The CSIST DICOM Gateway and Image Manager™ deals with medical images and associated data acquired from various imaging modalities (ultrasound, X-ray, etc.). It stores, communicates, processes, and displays these images. It does not analyze biological specimens.
- Intended Use: The intended use describes capturing, storing, communicating, processing, and displaying medical images. This aligns with medical imaging management systems, not IVD testing.
The device's function is centered around managing and processing medical images, which falls under the category of medical imaging systems and related software, not IVD.
N/A
Intended Use / Indications for Use
The CSIST DICOM Gateway and Image Manager™ is a device that captures 2 dimensional images and data or receives images and data from various medical imaging sources (i.e. ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data (2 dimensional or 3 dimensional) can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Product codes
90 LLZ
Device Description
CSIST DICOM Gateway and Image Manager™ consists of three modules: A DICOM Gateway, Image Manager Server, and Image Manager Client.
- The DICOM Gateway captures (2D) images from a non-DICOM imaging modality, generates a DICOM medical image, and stores it in the CSIST Image Manager Server.
- The CSIST Image Manager Server accepts DICOM medical images (2D and 3D) from different acquisition modalities, stores these in the Image Archive and then transfers the generated images to the requested Image Manager Client.
- The Image Manager Server also has a "Performed Procedure Step Manager", which can issue a message to department system scheduler/order filler and the Image Manager Server, when the acquisition modality informs the Performed Procedure Step Manager that a specific procedure step has been started or completed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows a logo with a trident symbol inside a black circle. To the right of the circle, the text "CSIST" is written in a simple, sans-serif font. The trident is stylized with three points at the top and a central vertical line intersecting a horizontal bar. The overall design is simple and monochromatic.
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
October 12, 2001
Submitter's Information: 21 CFR 807.92(a)(1)
CSIST (Chung-Shan Institute of Science and Technology) 481 Chia-An Sec. Chung-Cheng Road Chia-An Village, Lung Tan 32500; Taoyuan Taiwan, R.O.C.
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | CSIST DICOM Gateway and Image Manager™ System |
|---|---|
| Common Name: | Frame Grabber and Viewing Workstation |
| Classification Name: | Picture Archiving and Communications System |
| Device Classification: | 21 CFR 892.2050 |
Predicate Device: 21 CFR 807. 92(a)(3)
| Manufacturer | OLICON Imaging Systems, Inc. | A.L.I. Technologies, Inc |
|---|---|---|
| Device Name | OLICON 02 Workstation & PACS | |
| View Software | ALI 3D Tool Module for | |
| Medical Images | ||
| K Number | K973959 | K003762 |
| Decision Date | 12/22/97 | 2/28/01 |
| Product Code | 90 LMD | 90 LLZ |
| Classification | Class II | Class II |
Device Description: 21 CFR 807 92(a)(4)
CSIST DICOM Gateway and Image Manager™ consists of three modules: A DICOM Gateway, Image Manager Server, and Image Manager Client.
- 내 The DICOM Gateway captures (2D) images from a non-DICOM imaging modality, generates a DICOM medical image, and stores it in the CSIST Image Manager Server.
- ( The CSIST Image Manager Server accepts DICOM medical images (2D and 3D) from different acquisition modalities, stores these in the Image Archive and then transfers the generated images to the requested Image Manager Client.
510(k) submission for CSIST DICOM Gateway and Image Management™
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Image /page/1/Picture/0 description: The image shows a black and white logo. The logo consists of a circle with a trident-like symbol inside. The trident has three prongs pointing upwards. To the right of the circle, the text "CSIST" is written in a simple font, with a horizontal line underneath it.
- The Image Manager Server also has a "Performed Procedure Step Manager", 해 which can issue a message to department system scheduler/order filler and the Image Manager Server, when the acquisition modality informs the Performed Procedure Step Manager that a specific procedure step has been started or completed.
Indications for Use: 21 CFR 807 92(a)(5)
The CSIST DICOM Gateway and Image Manager™ is a device that captures 2 dimensional images and data or receives images and data from various medical imaging sources (i.e. ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data (2 dimensional or 3 dimensional) can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being printed.
Conclusion: 21 CFR 807 92(b)(1)
The two predicate devices (K003762 and K973959) and the new CSIST Gateway & Image Manager device are medical image PACS devices that are substantially equivalent in areas of design, general function, intended use, safety, and efficacy. Any differences between the two devices will not affect safety and effectiveness.
The CSIST DICOM Gateway & Image Manager is substantially equivalent to the OLICON 02 Workstation & PACS View Software (K973959) for image acquisition and image management for non-3D images and substantially equivalent to ALI 3D Tool Module (K003762) used with the ALI Ultra PACS for viewing and image management of 3D images.
The CSIST DICOM Gateway and Image Manager™ system has been and will be designed and manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
The submission contains the results of a hazard analysis and all potential hazards have been classified as Minor.
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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2001
CSIST % Mr. Carl Alletto Otech, Inc. 1100 Lakeview Blvd. DENTON TX 76208 Re: K012327
Trade/Device Name: CSIST DICOM Gateway and Image Manager Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: October 14, 2001 Received: October 18, 2001
Dear Mr. Alletto:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to regally atment date of the Medical Device Amendments, or to conniered pror to May 20, 1978, and the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrororo, market of the Act include requirements for annual registration, listing of general controls provisions of taxtice, 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 your device is thankled (600 a00 10) . Existing major regulations affecting your device can be it may of Subjoct to additions, 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 that I Dri has made a associations administered by other Federal agencies. You must or any I oderal battle Act's requirements, including, but not limited to: registration and listing compry with and the rece required to the Part 801); good manufacturing practice requirements as set (21 OF IC Fat 801), lacemis (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by stems (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows a logo with a trident symbol inside a black circle. To the right of the logo, the letters "CSIS" are printed in a simple font. A horizontal line is drawn beneath the logo and the letters.
(Indications for Use Form)
510(k) Number: Kol 2327
Device Name:
The CSIST DICOM Gateway/Image Manager™
Indications for Use:
The CSIST DICOM Gateway and Image Manager™ is a device that captures 2 dimensional images and data or receives images and data from various medical imaging sources (i.e. ultrasound systems, R/F Units, computed & direct radiographic imaging boardod (from anture devices, scanners, imaging gateways or other imaging sources). Images and data (2 dimensional or 3 dimensional) can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. Y Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
David A. Levenson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Device
510(k) Number K012327
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