(37 days)
No
The summary describes a standard digital radiography system integrating a flat panel detector and PACS software, with no mention of AI or ML capabilities. The focus is on replacing film-based systems and improving workflow.
No.
The device is described as an imaging system for digital image capture in radiographic examinations and does not mention any therapeutic function.
No
The device is described as an image capture system for general radiographic examinations and does not mention any diagnostic capabilities beyond image acquisition and viewing.
No
The device description explicitly states it is an "integrated flat panel digital detector (FPD)" and a "Digital Radiography system," which includes hardware components in addition to 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 that the device is for "digital image capture use in general radiographic examinations." This involves capturing images of the internal structures of the body using X-rays.
- Device Description: The description details a Digital Radiography system with a flat panel detector and image viewing/acquire software. This is consistent with a medical imaging device used for diagnostic purposes, but not for testing samples in vitro (outside of the living body).
- 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 diagnostic testing.
In summary, the ViZion DR system is a medical imaging device used for capturing radiographic images of the human body, which falls under the category of diagnostic imaging, not in vitro diagnostics.
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 two cleared devices: ViZion DR, K102123 and K102587, the Samsung Digital Flat Panel.
ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) (K102587, Samsung Flat-Panel X-Ray Detector), made by Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. 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 film less. environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and Samsung FPD were not changed. Our main predicate is ViZion DR, K102123, wherein we combined our OPAL-RAD software with the Samsung panel cleared in K090742. Only the panel has changed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital Radiography
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)
The results of clinical inage inspection, bench, and test laboratory indicates that the new device is as of e and effective as the predicate devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates.
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.
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112661 Page I of 2 510(k) Summarv 510(k) Number K11
Viztek, LLC. 6491 Powers Avenue Jacksonville, FL 32217 Phone: 800.366.5343 Fax: 904.448.9936 Date Prepared: August 9, 2011 Contact: Bruce Ashby, Sales and Marketing Manager
- l. 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 gencral radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and manınography. 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 4. two cleared devices: ViZion DR, K102123 and K102587, the Samsung Digital Flat Panel.
ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) (K102587, Samsung Flat-Panel X-Ray Detector), made by Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. 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 film less. environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and Samsung FPD were not changed. Our main predicate is ViZion DR, K102123, wherein we combined our OPAL-RAD software with the Samsung panel cleared in K090742. Only the panel has changed.
-
- Safety and Effectiveness, comparison to predicate device. The results of clinical inage inspection, bench, and test laboratory indicates that the new device is as of e and effective as the predicate devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates.
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K112661 Page 2 of 2
6. Substantial Equivalence Chart
| Characteristic | Viztek ViZion DR K102123 | Viztek ViZion DR |
|---|---|---|
| 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 extremitics. | 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. | ||
| Digital Panel | Samsung LTX240AA01-A (K090742) | |
| Pixel size 143 µm | ||
| 3072 x 3072 pixels | ||
| 9 million pixels. | Samsung LLX240AB01 (K102587) | |
| Pixel size 143 um | ||
| 3072 x 3072 pixels | ||
| 9 million pixels. | ||
| Software | Employs OPAL-RAD PACS image | |
| viewing and acquire interface software | ||
| technology, K063337 | SAME | |
| Electrical safety | Electrical Safety per IEC-60601. UL | |
| listed | SAME |
7. Conclusion
After analyzing bench, inage, 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 equivalein to the predicate device. ı
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a single staff entwined by a serpent.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Viztek LLC % Mr. Daniel Kamm Principal Engineer 8870 Ravello Ct NAPLES FL 34114
Re: K112661
Trade/Device Name: ViZion DR. Digital Flat Panel X=Ray Detector System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: September 9, 2011 Received: September 19, 2011
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/cdrh/industry/support/index.html.
Sincerely Yours.
Mary. Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
KI12661
Indications for Use
510(k) Number (if known): K11266
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)
Mary Postel
Page 1 of I
(Division Sian-Of Division of Radiological De Office of In Vitro Diagnostic Device Eva 510K