(46 days)
No
The summary describes a digital radiography system with a new detector panel and previously cleared software, focusing on image capture and replacement of film. There is no mention of AI, ML, or related concepts, nor any description of training or test sets typically associated with such technologies.
No
The device is described as a digital x-ray system intended for image capture in radiographic examinations, not for therapeutic purposes.
No
Explanation: The device is described as an image capture system (Digital X-Ray) for general radiographic examinations, and its intended use focuses on providing images for viewing, not on making a diagnosis or providing diagnostic interpretations.
No
The device description explicitly states it is an "integrated flat panel digital detector (FPD)" and a "Digital Radiography system," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is a digital X-ray system used for capturing images of the internal structures of the body directly.
- The intended use and device description clearly state it's for general radiographic examinations. This involves imaging the skull, chest, spine, etc., which is a form of in vivo imaging (imaging within the living body), not in vitro (imaging outside the living body).
- There is no mention of analyzing biological samples or performing tests on specimens.
Therefore, based on the provided information, the ViZion + DR system is a medical imaging device, specifically a digital radiography system, and not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The ViZion + DR system represents the straightforward integration of a new digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K112661 wherein we have changed the supplier of the panel.
ViZion + DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) ViZion + is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion DR, K112661, wherein we combined our OPAL-RAD software with a new digital panel. We now also offer two sizes of panels: 14" x 17" and 17" x 17" panels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Solid State X-Ray Imager (Flat Panel/Digital Imager)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical images were acquired and evaluated by a board certified radiologist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
510(k) Summary 510(k) Number K12 364 Y
JAN 1 1 2013
Viztek, LLC. 6491 Powers Avenue Jacksonville, FL 32217 Phone: 800.366.5343 Fax: 904.448.9936 Date Prepared: November 9, 2012 Bruce Ashby, Sales and Marketing Manager Contact:
-
- Identification of the Device: Proprietary-Trade Name: ViZion + DR Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) 90 MQB, Common/Usual Name: Digital X-Ray Receptor Panel
-
- Indications for Use (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.
-
- Description of the Device: The ViZion + DR system represents the straightforward integration of a new digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K112661 wherein we have changed the supplier of the panel.
- ViZion + DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) ViZion + is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion DR, K112661, wherein we combined our OPAL-RAD software with a new digital panel. We now also offer two sizes of panels: 14" x 17" and 17" x 17" 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.
1
6. Substantial Equivalence Chart
| Characteristic | Viztek ViZion DR | Atlaim ATAL 8, K113812. | Viztek ViZion + DR |
|---|---|---|---|
| K112661 | |||
| 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. | The ATAL 8 and ATAL | ||
| 8c is indicated for use 'in | |||
| general radiographic | |||
| images of human anatomy. | |||
| It is intended to replace | |||
| radiographic film/screen | |||
| systems in all general- | |||
| purpose diagnostic | |||
| procedures, | |||
| excluding fluoroscopic, | |||
| angiographic, and | |||
| mammographic | |||
| applications | 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. | |||
| 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 μm | |||
| 3072 x 3072 pixels 9 | |||
| million pixels. | Pixel size 139 μm | ||
| 3072 X 3072 pixels (9 | |||
| million pixels | iRay Technology | ||
| (Shanghai) Ltd. | |||
| For the 17" x 17" panel: | |||
| Pixel size 139 μm | |||
| 3064×3072 pixels (9 | |||
| million pixels) | |||
| For the 14" x 17" panel: | |||
| Pixel size 150 μm | |||
| 2288×2800 pixels (6.4 | |||
| million pixels) | |||
| Software | Employs OPAL-RAD | ||
| PACS image viewing and | |||
| acquire interface software | |||
| technology, K063337 | The Atal-8 can be used | ||
| with any FDA-cleared off- | |||
| the-shelf radiographic | |||
| image acquisition software | |||
| package that outputs a | |||
| suitable DICOM image | |||
| like OmniVision software | |||
| by OmniVision, cleared | |||
| under K110040. | SAME as K112661, outputs a DICOM image. | ||
| DICOM | Yes | Option | Yes |
| Power source | AC Line | AC Line | AC Line |
| Electrical | |||
| safety and | |||
| EMC | Electrical Safety per IEC- |
- 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, Risk Analysis and Software validation was conducted in accordance with FDA guidance documents. .
2
-
- 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 or better than the images acquired with the predicate panel.
-
- Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Viztek Inc that the Viztek ViZion + DR is as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
3
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 stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 11, 2013
Viztek LLC % Mr. Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114
Re: K123644
Trade/Device Name: ViZion + DR. Digital Flat Panel X-Ray Detector System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB Dated: November 15, 2012 Received: November 28, 2012
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
4
Page 2-Mr. Kamm
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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,
Sean M. Boyd -S
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): K12:3644
Device Name: ViZion + DR, Digital Flat Panel X-Ray Detector System
Indications For 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Sean M.Boyd -S.
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological
51000 K123644
Page 1 of 1 .