(169 days)
Not Found
No
The description focuses on standard image management and editing functionalities within a PACS environment, with no mention of AI or ML terms or capabilities.
No
Explanation: A therapeutic device is used to treat or cure a disease or condition. Visix Imaging is an image management system that acquires, displays, edits, reviews, stores, prints, and distributes images and clinical notes. It does not perform any therapeutic function.
No
The device is an image management system (PACS) for acquiring, displaying, editing, reviewing, storing, printing, and distributing medical images. It does not perform any diagnosis on its own, but rather facilitates the management of images that may be used by a physician for diagnostic purposes.
Yes
The device is described as a "clinical software application" and an "image management system" that "runs on standard PC-compatible computers." While it interacts with hardware (capture devices, PCs), the device itself is the software component performing the image management functions. The description does not indicate that the submission includes any hardware components or their verification/validation.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Visix Imaging's function: Visix Imaging is a software application that manages and processes medical images acquired from imaging devices (radiographic, video, scanners). It deals with visual data, not biological samples.
- Intended Use: The intended use clearly states it receives images and data from imaging sources and is used for acquiring, displaying, editing, reviewing, storing, printing, and distributing images and clinical notes. This is consistent with image management and processing, not diagnostic testing of biological samples.
Therefore, Visix Imaging falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Visix Imaging is a clinical software application that receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). Visix Imaging is intended to acquire, display, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images, plus store clinical notes in the form of annotations and measurements, using standard PC hardware. Visix Imaging is currently intended for dental use. It is not intended for mammography use.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Visix Imaging is an image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. Visix Imaging runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a USB port, parallel port, S-video port on a video capture card, or SCSI card.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / clinical software application
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)
Visix Imaging has been demonstrated to perform as intended.
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.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
1082623
Televere Systems Section 005_510(k) Summary 510(k) Premarket Notification
Visix Imaging Page 1 of 2
CONFIDENTIAL
510(k) SUMMARY
FEB 2 5 2009
General Information
Submitted by:
Televere Systems 1611 Center Avenue Janesville, WI 53545
Phone: 800-385-9593 Fax: 608-314-1084
Contact Person:
Barbara Deay 471 Stage Road Charlton, NY 12019
Phone: 800-385-9593 x128 408-762-2760 Fax: Email: barb@tigerview.com
Date Prepared:
August 29, 2008
Device Name
Trade Name: Visix Imaging Common Name: Picture archiving and communications system Classification Name: System, Image Processing, Radiological, 21 CFR 892.2050
Predicate Device
| Manufacturer | Product Name | 510(k) No. |
|---|---|---|
| Televere Systems | TigerView Professional | K061035 |
| EagleSoft | EagleSoft ChairSide Software | |
| Application | K982422 | |
| Tau Corp. (purchased by | ||
| Televere Systems) | TigerScan/TigerView | K955237 |
1
Televere Systems Section 005_510(k) Summary Visix Imaging Page 2 of 2
CONFIDENTIAL
Device Description
Visix Imaging is an image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. Visix Imaging runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a USB port, parallel port, S-video port on a video capture card, or SCSI card.
Intended Use
Visix Imaging is a clinical software application that receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). Visix Imaging is intended to acquire, display, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images, plus store clinical notes in the form of annotations and measurements, using standard PC hardware. Visix Imaging is currently intended for dental use. It is not intended for mammography use.
Technological Comparison
Visix Imaging, Tiger View Professional, Tiger View, and EagleSoft ChairSide are each software applications that have similar indications for use and overall function and perform in a similar manner with respect to image processing systems (i.e. PACS).
Testing
Visix Imaging has been demonstrated to perform as intended.
Conclusions
Visix Imaging is substantially equivalent to legally marketed Picture Archiving and Communications Systems.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three arms or extensions, representing health and human services. The overall design is simple and recognizable, conveying the department's role and purpose.
DEPARTMENT OF HEALTH & HUMAN SERVICES
· Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2009
Televere Systems % Ms. Barbara Deay . Technical Support and Writing Televere Systems 471 Stage Road CHARLTON NY 12019
Re: K082623
Trade/Device Name: Visix Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 11, 2009 Received: January 14, 2009
Dear Ms. Deay:
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. Drue, 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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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; 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx |
|---|
| 21 CFR 884.xxx |
| 21 CFR 892.xxx |
| Other |
(Gastroenterology/Renal/Urology) (240) 276-0115 (Obstetrics/Gynecology) (240) 276-0115 (Radiology) (240) 276-0120 (240) 276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification Televere Systems Section 004 _Indications for Use Statement
Visix Imaqinq Page 1 of 1
INDICATIONS FOR USE
510(k) Number (if known): K082623
Visix Imaging Device Name:
Sponsor Name: : Televere Systems
Indications for Use:
Visix Imaging is a clinical software application that receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). Visix Imaging is intended to acquire, display, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images, plus store clinical notes in the form of annotations and measurements, using standard PC hardware. Visix Imaging is currently intended for dental use. It is not intended for mammography use.
Prescription Use X (21 CFR 801 Subpart D)
And/Or
Over-The-Counter Use (21 CFR 807 Subpart C)
Do Not Write Below This Line - Continue on Another Page if Needed Concurrence of CDRH, Office of Device Evaluation (ODE)
Tony Thien
(Division Sign-Off) Division of Reproductive. Abdominal and Radiologics' " ﮨﮯ-------510(k) Num. ..
August 29, 2008