(29 days)
No
The summary explicitly states that the only modifications are related to making the panel wireless and battery-operated. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a diagnostic imaging system (Digital Radiography system) used for image capture in general radiographic examinations, not for treating any condition.
Yes
A diagnostic device is used to identify or diagnose a disease or condition. This device is described as a "Digital Radiography system" intended for "digital image capture use in general radiographic examinations" of various anatomical sites. Radiographic examinations are a common method for diagnosing medical conditions.
No
The device description explicitly states it is an "integrated flat panel digital detector (FPD)" and a "modified digital x-ray receptor panel," which are hardware components. The modification is specifically about making the panel wireless.
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 is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The description details a "Digital Radiography system, featuring an integrated flat panel digital detector (FPD)." This is consistent with medical imaging equipment used to produce X-ray images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
The device is a medical imaging system used for capturing radiographic images of the human 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 + Wireless allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
Product codes
MOB
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 K123644 wherein we have changed panel to a wireless version of the previously cleared panel/software combination. Going wireless (with batterv operation possible) are the ONLY modifications.
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 +, K123644. 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 was conducted including Electrical Safety and Electromagnetic Compatibility per IEC Standards. MTF and DOE 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. Wireless communication testing was performed to verify wireless connectivity. 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.)
MTF: 0.75 at 0.5 (1/mm) (Essentially the same as predicate)
DQE: 0.27 at 0.5 (1/mm) (Essentially the same as predicate)
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
Viztek LLC % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K152279
Trade/Device Name: ViZion DR + Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: August 4, 2015 Received: August 12, 2015
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.
1
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/Resourcesfor You/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,
Robert Oolo
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152279
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) Summary 510(k) Number K152279 Viztek, LLC. 2217 US HWY 70 East • Garner, NC 27529 Phone: 800.366.5343 Fax: 904.448.9936 Date Prepared: September 10, 2015 Contact: Bruce Ashby, Sales and Marketing Manager
-
- Identification of the Device: Proprietary-Trade Name: ViZion DR + Wireless 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
-
- Equivalent legally marketed device: ViZion DR +, K123644, Viztek. 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
-
- 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 K123644 wherein we have changed panel to a wireless version of the previously cleared panel/software combination. Going wireless (with batterv operation possible) are the ONLY modifications.
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 +, K123644. 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 devices. 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 K123644 | ViZion DR + Wireless | |
|---|---|---|
| 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 + | ||
| allows imaging of the skull, chest, shoulders, | ||
| spine, abdomen, pelvis, and extremities. | UNCHANGED | |
| Configuration | This submission is for the Digital Panel and | |
| Software only, no generator or stand | ||
| provided. | UNCHANGED | |
| Digital Panel | iRay Technology (Shanghai) Ltd. | |
| For the 14" x 17" panel: | ||
| Pixel size 150 μm | ||
| 2288×2800 pixels (6.4 million pixels) | iRay Technology (Shanghai) Ltd. | |
| Mars1417V | ||
| 14" x 17" panel: Pixel size 150 μm | ||
| 2304×2800 (6.4 million pixels) | ||
| Software | Outputs a DICOM image. | SAME as K123644 |
| DICOM 3 | Yes | YES |
| A/D | ||
| Conversion | 14 bit | SAME |
| MTF | 0.75 at 0.5 (1/mm) | 0.75 at 0.5 (1/mm) (Essentially the same) |
| DQE | 0.23 at 0.5 (1/mm) | 0.27 at 0.5 (1/mm) (Essentially the same) |
| Scintillator | GOS scintillation screen. | UNCHANGED |
| Interface | Gigabit Ethernet | Wired : Gigabit Ethernet (1000BASE-T) |
| Wireless : IEEE802.11a/b/g/n | ||
| Power source | AC Line | AC Line and/or Rechargeable Lithium Battery |
| (3 hr run time) | ||
| Photo | Image: Viztek ViZion + DR K123644 | Image: ViZion DR + Wireless |
| Electrical | ||
| safety and EMC | Electrical Safety per IEC 60601-1 and EMC | |
| per IEC 60601-1-2. | SAME, plus complies with FCC Part 15 Rules | |
| and Regulations |
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- Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility. We compared MTF and DOE measurements for the original and wireless versions of the panel and found them 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. We used a Cisco Linksys EA2700. The device was also found to comply with FCC requirements for wireless operation.
-
- 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 ViZion DR + Wireless 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.