(57 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware modification (scintillator change) and integration with existing software, with no mention of AI/ML capabilities.
No
The device is described as a Digital Radiography system intended for diagnostic image capture, not for therapeutic (treatment) purposes.
Yes
Explanation: The device is a Digital Radiography system used for capturing digital images of various anatomical sites (skull, chest, shoulders, spine, abdomen, pelvis, and extremities) for examinations. Medical imaging devices like X-ray systems are used by healthcare professionals to diagnose conditions by visualizing internal structures of the body.
No
The device description explicitly states it is an "integrated flat panel digital detector (FPD)" and a "modified digital x-ray receptor panel," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "digital image capture use in general radiographic examinations." This involves capturing images of the human body using X-rays.
- Device Description: The description details a "Digital Radiography system" that replaces conventional film for radiographic examinations.
- Input Imaging Modality: The input is "Digital X-Ray," which is an imaging technique applied to the patient, not a test performed on a sample taken from the patient.
- Anatomical Site: The device is used to image various parts of the human body (skull, chest, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is an imaging system used to visualize internal structures of the body.
N/A
Intended Use / Indications for Use
ViZion DR + Wireless 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 DR + Wireless 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 + Wireless system represents the straightforward integration of a modified digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K152279 wherein we have changed the panel scintillator to Cesium Iodide in addition to having the GOS scintillator available. Changing the scintillator is the only modification.
ViZion DR + Wireless is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD). ViZion DR + Wireless 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 predicate is ViZion DR + Wireless, K152279. We do not supply the router, but any router meeting the IEEE 802.11 a/b/g/n specifications will work. With the advent of AED (automatic exposure detection) by the panel, integration with or connection to specific generators is no longer required. If the user decides NOT to use AED, wired synchronization with Sedecal Series SHF generators is known to work.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing, clinical image inspection, and external laboratory testing were conducted. IEC Standards were employed for Electrical Safety and Electromagnetic Compatibility. MTF and DQE measurements for the original and wireless versions of the panel were compared and found to be similar enough not to make a notable difference in acquired images. Risk Analysis and System operation verification tests were conducted in accordance with FDA guidance documents. Since no software modifications were required, confirmation testing was performed. Wireless communication testing was performed to verify wireless connectivity. The device was also found to comply with FCC requirements for wireless operation.
Clinical images were acquired and evaluated by a board certified radiologist who concluded the images from the modified panel are as good as or better than the images acquired with the predicate panel.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MTF: 0.83 at 0.5 (1/mm) (CSI) (Better than predicate's 0.75 at 0.5 (1/mm) (GOS))
DQE: 0.55 at 0.5 (1/mm) (CSI) (Better than predicate's 0.27 at 0.5 (1/mm) (GOS))
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.
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
Viztek LLC % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114
Re: K160810
Trade/Device Name: Vizion Dr + Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: March 21, 2016 Received: March 24, 2016
Dear Daniel 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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
Robert Ochs Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K16
Device Name ViZion DR + Wireless
Indications for Use (Describe)
Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion DR + Wireless 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) |
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510(k) Summarv 510(k) Number K160810 Viztek, LLC. 2217 US HWY 70 East • Garner, NC 27529 Phone: 800.366.5343 Fax: 904.448.9936 Date Prepared: April 5, 2016 Bruce Ashby, Sales and Marketing Manager Contact:
-
- Identification of the Device: Proprietary-Trade Name: ViZion DR + Wireless Classification Name: Stationary x-ray system. Product Code MOB Common/Usual Name: Digital X-Ray Receptor Panel Device Class/Regulation Number: Class II per regulation 892.1680
-
- Equivalent legally marketed device: ViZion DR + Wireless, K152279, Viztek. Classification Name: Stationary x-ray system, Product Code MQB Common/Usual Name: Digital X-Ray Receptor Panel Device Class/Regulation Number: Class II per regulation 892.1680
-
- Indications for Use (intended use) ViZion DR + Wireless 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 + Wireless allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
-
- Description of the Device: The ViZion DR + Wireless system represents the straightforward integration of a modified digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K152279 wherein we have changed the panel scintillator to Cesium Iodide in addition to having the GOS scintillator available. Changing the scintillator is the only modification.
ViZion DR + Wireless is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD). ViZion DR + Wireless 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 predicate is ViZion DR + Wireless, K152279. We do not supply the router, but any router meeting the IEEE 802.11 a/b/g/n specifications will work. With the advent of AED (automatic exposure detection) by the panel, integration with or connection to specific generators is no longer required. If the user decides NOT to use AED, wired synchronization with Sedecal Series SHF generators is known to work.
-
- 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 device. Clinical images collected demonstrate equal or better image quality as compared to our predicate.
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6. Substantial Equivalence Chart
| Viztek ViZion DR + Wireless K152279 | ViZion DR + Wireless, CSI Scintillator | |
|---|---|---|
| Intended Use: | Intended for digital image capture use in | |
| general radiographic examinations, wherever | ||
| conventional screen-film systems may be | ||
| used, excluding fluoroscopy, angiography and | ||
| mammography. ViZion + Wireless allows | ||
| imaging of the skull, chest, shoulders, spine, | ||
| abdomen, pelvis, and extremities. | UNCHANGED | |
| Configuration | Digital Panel and Software only, no generator | |
| or stand provided. | UNCHANGED | |
| Digital Panel | iRay Technology (Shanghai) Ltd. | |
| Mars1417V-PSI 14" x 17" panel: | ||
| Pixel size 150 µm | ||
| $2304\times2800$ (6.45 million pixels) | iRay Technology (Shanghai) Ltd. | |
| Mars1417V-TSI 14" x 17" panel: | ||
| Pixel size 150 µm | ||
| $2288x2784$ (6.37 million pixels) | ||
| NOT a meaningful DIFFERENCE. | ||
| Internal | ||
| image storage | 200 full size images | UNCHANGED |
| Image | ||
| acquisition | ||
| time |