(168 days)
No
The summary describes a digital radiography system with a new detector panel and previously cleared software. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on replacing film with digital technology and integrating with PACS.
No.
The device is used for digital image capture in general radiographic examinations, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for digital image capture in general radiographic examinations, which are used to produce images that physicians interpret to diagnose or rule out medical conditions.
No
The device description explicitly states that the system integrates a new digital x-ray receptor panel (hardware) with previously cleared software. It is a modification of a system that includes hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "digital image capture use in general radiographic examinations." This describes a device used for medical imaging of the human body, not for testing samples taken from the body (which is the core function of an IVD).
- Device Description: The description details a "Digital Radiography system" featuring a "flat panel digital detector (FPD)" and software for image acquisition and processing. This aligns with the description of an X-ray imaging system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is a medical imaging device used for diagnostic purposes, but it operates by capturing images of the internal structures of the body using X-rays, not by performing tests on samples outside the body.
N/A
Intended Use / Indications for Use
ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
Product codes
MQB
Device Description
The ViZion Ultra system represents the straightforward integration of a new digital x-ray receptor panel (K110849) and our previously cleared software. This is a MODIFICATION of our clearances K112661 and K123644 wherein we have changed the supplier of the panel. Therefore a special 510(k) has been submitted. The ViZion Ultra is compatible with Sedecal SHF generators. Some manufacturers rebrand the Sedecal SHF generators, and these generators are compatible as well.
ViZion Ultra is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) ViZion Ultra is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advartages of digital radiography for a filmless environment and improves cost effectiveness. The major funciple of operation of the Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion + DR, K123644, wherein we combined our OPAL-RAD software with two new digital panels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Clinical images were acquired and evaluated by a board certified radiologist who concluded the images from the new panel are as good as the images acquired with the predicate panel.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only 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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page 1 of 2
510(k) Summary 510(k) Number K133139 Viztek, LLC. 6491 Powers Avenue Jacksonville, FL 32217 Phone: 800.366.5343, Fax: 904.448.9936 Date Prepared: February 22, 2014 Bruce Ashby, Sales and Marketing Manager Contact:
-
- Identification of the Device: Proprietary-Trade Name: ViZion Ultra Classification Name: Stationary X-Ray System, Product Code MQB, Requlation 892.1680 Common/Usual Name: Digital X-Ray Receptor Panel
- Equivalent legally marketed device: Viztek ViZion DR, K112661 and Viztek ViZion + DR, K123644. 2.
-
- Indications for Use ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
-
- Description of the Device: The ViZion Ultra system represents the straightforward integration of a new digital x-ray receptor panel (K110849) and our previously cleared software. This is a MODIFICATION of our clearances K112661 and K123644 wherein we have changed the supplier of the panel. Therefore a special 510(k) has been submitted. The ViZion Ultra is compatible with Sedecal SHF generators. Some manufacturers rebrand the Sedecal SHF generators, and these generators are compatible as well.
ViZion Ultra is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) ViZion Ultra is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advartages of digital radiography for a filmless environment and improves cost effectiveness. The major funciple of operation of the Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion + DR, K123644, wherein we combined our OPAL-RAD software with two new digital panels.
-
- Safety and Effectiveness, comparison to predicate device. The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates.
| Characteristic | Viztek ViZion DR K112661 | ViZion + DR, K123644 | Viztek ViZion Ultra K133139 |
|---|---|---|---|
| Intended Use: | ViZion DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. | ViZion + DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion + allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities | ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. |
6. Substantial Equivalence Chart
1
K.1331.39
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| Characteristic | Viztek ViZion DR K112661 | ViZion + DR, K123644 | Viztek ViZion Ultra
K133139 |
|------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Configuration | This submission is for the
Digital Panel and Software
only, no generator or stand
provided. | This submission is for the
Digital Panel and Software
only, no generator or stand
provided. | This submission is for the
Digital Panel and Software
only, no generator or stand
provided. |
| Digital Panel | Samsung LTX240AA01-A
(K090742)
Pixel size 143 $ \mu $ m
3072 x 3072 pixels | iRay Technology (Shanghai)
Ltd. For the 17" x 17" panel:
Pixel size 139 $ \mu $ m
3064×3072 pixels
For the 14" x 17" panel:
Pixel size 150 $ \mu $ m
2288×2800 pixels | Trixell Pixium Rad 4143
2880 (h) x 2880 (v) pixels,
pitch. 148 $ \mu $ m (h) x 148 $ \mu $ m (v)
(K110849) |
| Software | Employs OPAL-RAD PACS
image viewing and acquire
interface software technology,
K063337 | SAME as K112661,
outputs a DICOM image. | SAME as K112661,
outputs a DICOM image. |
| DICOM | Yes | Yes | Yes |
| Power source | AC Line | AC Line | AC Line |
| Electrical safety
and EMC | Electrical Safety per IEC-
60601. UL listed | Electrical Safety per IEC
60601-1 and EMC per IEC
60601-1-2. | Electrical Safety per IEC
60601-1 and EMC per IEC
60601-1-2. |
-
- Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility. MTF and DQE measurements were supplied by the panel manufacturer in accordance with the FDA guidance document. Risk Analysis was conducted in accordance with FDA guidance documents.
-
- Summary of Clinical Testing: Clinical images were acquired and evaluated by a board certified radiologist who concluded the images from the new panel are as good as the images acquired with the predicate panel.
- Conclusion: After analyzing bench, clinical image, and external laboratory testing to 9. applicable standards, it is the conclusion of Viztek Inc that the Viztek ViZion Ultra is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the top half of the circle. Inside the circle is an image of an eagle with its wings spread, with three lines extending from the eagle's body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2014
Viztek LLC % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K133139
Trade/Device Name: ViZion Ultra Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: February 27, 2014 Received: March 6, 2014
Dear Mr. Kamm:
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. 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 (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.
3
Page 2 - Daniel Kamm, P.E.
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/ResourcesforYou/Industry/default.htm. 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 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/Resourcesfor You/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
4
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510{k} Number (if known) K133139
Device Name
Vizion Ultra, Digital Flat Panel X-ray Detector System
Indications for Use (Describe)
ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sm. 7)
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