(80 days)
Not Found
No
The description focuses on data acquisition, transformation to DICOM format, storage, and transfer, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as a software package for image acquisition, storage, and transfer in DICOM format, and it is not described as having any therapeutic function.
No
The device acquires, transforms, records, stores, and transfers imaging data to DICOM format and transmits it to PACS. It does not perform any analysis or interpretation of the data to diagnose a condition.
Yes
The device is described as a "software package" installed on an "Off-The-Shelf Host PC". While it interfaces with hardware (Host PC, LAN, Host Acquisition Device), the core medical device functionality described is the software's ability to acquire, transform, store, edit, and transfer medical imaging data in DICOM format. The hardware components are described as platforms or interfaces for the software, not integral parts of the medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The described device is a software package that focuses on acquiring, transforming, storing, and transferring medical images and related data (text, video) into the DICOM format for use within a hospital network (PACS). It handles existing medical data, not specimens from the human body.
- Intended Use: The intended use is to manage and format medical imaging data, not to perform diagnostic tests on biological samples.
- Lack of Biological Specimen Handling: There is no mention of the device interacting with or analyzing biological specimens.
The device is clearly focused on the management and standardization of medical imaging data, which falls under the category of medical imaging software or PACS-related devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The DICOM Video software package is intended for use by authorized personnel to acquire individual or sequences of images and to allow the user to input patient demographics related to the image. The device transforms imaging studies to DICOM format before they are made available to other locations in the network. The DICOM Video is indicated to receive studies in various digital formats (text, still images and video) or digitized video signals from acquisition host devices. The device operations include capturing the data, recording, storing, editing and transferring it to the clinic PACS as DICOM files.
Product codes
LMA
Device Description
The DICOM Video is a software package, which is installed in an Off - The - Shelf Host PC. The device is interfaced and configured to a hospital Local Area Network (LAN).
The DICOM Video receives patients' list from the Hospital Modality Work List (MWL ) server and digital files input data (in text, images or video formats). The device records the received data, stores it, transfers the studies into standard DICOM files, and transmits the DICOM files via the LAN to the Hospital PACS.
The DICOM Video can be interfaced to a Host Acquisition Device in order to receive analog video signals. The data is digitized, stored, optionally edited, transferred into standard DICOM files, and transmitted as DICOM files via the LAN to the Hospital PACS.
The device can also retrieve DICOM studies from the PACS and display them on the user screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized personnel / clinic
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
Bench data: The device performance has been verified by testing the software with respect to predefined software test plan. The device has been validated by testing the performance with respect to predefined test plan in end - user environment. Methods of testing the device safety & effectiveness adhere to state-of-art standards. The tests results demonstrated that the device output meet the design input and support the indications for use.
Key Metrics
Not Found
Predicate Device(s)
K000411 CHILI VIDEO/VIDEO PRO
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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K132183
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510(k) Summary of Safety and Effectiveness (in accordance to 21CFR 807.92)
Submitter details
Bar-Code Computers Ltd. 2 Hayozma St, Tirat Hacarmel 39120, Israel
Telephone +972-4-8509569
6 Sireni St., Haifa, 32972, Israel.
Details of the submitted Device
Preparation Date: 16th September 2013
Submission Contact: Dan Laor
Proprietary Name: Regulation Description: Regulation Number Product Code: Committee/Panel: Device Class:
DICOM Video Medical image digitizer. 892.2030 LMA Radiology ನ
OCT 03 2013
Reason for 510(k) Submission:
New Device
Identification of the Legally Marketed Predicate Device K000411 CHILI VIDEO/VIDEO PRO
Device Description
The DICOM Video is a software package, which is installed in an Off - The - Shelf Host PC. The device is interfaced and configured to a hospital Local Area Network (LAN).
The DICOM Video receives patients' list from the Hospital Modality Work List (MWL ) server and digital files input data (in text, images or video formats). The device records the received data, stores it, transfers the studies into standard DICOM files, and transmits the DICOM files via the LAN to the Hospital PACS.
The DICOM Video can be interfaced to a Host Acquisition Device in order to receive analog video signals. The data is digitized, stored, optionally edited, transferred into standard DICOM files, and transmitted as DICOM files via the LAN to the Hospital PACS.
The device can also retrieve DICOM studies from the PACS and display them on the user screen.
Intended use and indications for Use
The DICOM Video software package is intended for use by authorized personnel to acquire individual or sequences of images and to allow the user to input patient demographics related to the image. The device transforms imaging studies to DICOM format before they are made available to other locations in the nework. The DICOM Video is indicated to receive studies in various digital formats (text, still images and video) or digitized video signals from acquisition host devices. The device operations include capturing the data, recording, storing, editing and transferring it to the clinic PACS as DICOM files.
Comparison with the predicate device
Intended Use & Indications For Use: Similar to the predicate device, the DICOM Video is intended for use by authorized personnel to acquire individual or sequences of images. Both devices allow the user to input patient demographics. In addition the DICOM Video transforms
Section 5_510K Summary
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K132183
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,
imaging studies to DICOM format before they are made available to other locations in the network.
Similar to the predicate device, the DICOM Video is indicated to receive studies in various formats. The devices' operations include capturing the data, recording, storing and editing. In addition the DICOM Video is communicating DICOM files with the hospital PACS .
| Category | Predicate Device
K000411 CHILI
VIDEO/VIDEO PRO | Subject Device
DICOM Video |
|-------------------------------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------|
| Used to grab images from
modalities that do not have
digital export functions | Yes | Yes |
| Data Capture: Can grab
single images | Yes | Yes |
| Data Capture: Can grab
sequence images | Yes | yes |
| Viewing | Yes | Yes |
| Editing | Yes | Yes |
| Storing | Yes | Yes |
| Grabbed image can be
manipulated. | No | No |
| Images can be added to a
study | Yes | No |
| user enters patient
demographic data | Yes | Yes |
| Images can be stored
with demographic data | Yes | yes |
| Data Source | Includes: Still images & Video | Includes: Files of Text,
Still images & Video |
| Control s | Software package included | Software package
included |
| Supporting Hardwar PC | Included | Company specified PC |
| Frame grabber | Various boards available | Company specified board |
| Can be used with any
device that has a video
data stream output | Yes | S Video & Composite
formats, ONLY |
| User selectable video
sources | Yes | Pre-selected single video
source, only |
| Communication | Not provided | TCP/IP Ethernet using
DICOM 3.0 protocol |
Characteristics Comparison
Section 5_510K Summary
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K132183
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Design Verification and Validation
The device has been designed, verified and validated complying to 21CFR 820.30 regulations. The device was tested in conformance to the requirements of NEMA PS 3.1 - 3.20 (2011) DICOM (Digital Imaging and Communications in Medicine) set and was found conforming.
Performance data
Bench data:
The device performance has been verified by testing the software with respect to predefined software test plan.
The device has been validated by testing the performance with respect to predefined test plan in end - user environment.
Methods of testing the device safety & effectiveness adhere to state-of-art standards. The tests results demonstrated that the device output meet the design input and support the indications for use.
Clinical Data: Clinical data is not included.
Substantial Equivalence
The above presented data demonstrate that:
- The predicate device K000411 CHILI VIDEO/VIDEO PRO is legally marketed. ਕ.
- The submitted device and the predicate device have the same intended use. b.
- The technological characteristics are equivalent and do not raise different questions of C. safety and effectiveness.
Conclusion: Based on the data above, it is Bar Code Computers' opinion that the submitted device and the predicate device are substantial equivalent.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
October 3, 2013
Bar-Code Computers Ltd. % Mr. Dan Laor Q&R Consultant 6 Sireni Haifa 32972 ISRAEL
Re: K132183 Trade/Device Name: DICOM Video Regulation Number: 21 CFR 892.2030 Regulation Name: Medical Image Digitizer Regulatory Class: II Product Code: LMA Dated: July 8, 2013 Received: July 19. 2013
Dear Mr. Laor:
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 10 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. Iisting 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 11 (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 fimited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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.
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Page 2-Mr. Laor
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K132183
Device Name: DICOM Video
Indications for Use:
The DICOM Video software package is intended for use by authorized personnel to acquire individual or sequences of images and to allow the user to input patient demographics related to the image. The device transforms imaging studies to DICOM format before they are made available to other locations in the network. The DICOM Video is indicated to receive studies in various digital formats (text, still images and video) or digitized video signals from acquisition host devices. The device operations include capturing the data, recording, storing, editing and transferring it to the clinic PACS as DICOM files.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
$\sinh$
(Division Sign-Off) Division of Radiological Health Office of In Viro Diagnostics and Radiological Health
510(k) K132183
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