(152 days)
Not Found
No
The description focuses on standard image processing functions, database management, and client-server architecture, with no mention of AI or ML algorithms.
No
This device is a software package for managing and enhancing dental images for diagnostic purposes, not for providing therapy or treatment.
No
This device is designed as an imaging database for storage and organization of patient digital images and radiographs. While it allows for image enhancement for viewing and states it "does provide the tools that permit the user to enhance images for diagnostic purposes," it explicitly states that "Improvis Imaging does not control the x-ray taking system and does not generate x-ray images directly from the physical device." Furthermore, it does not provide any diagnostic interpretation or output. Its primary function is image management and enhancement, not diagnosis. The predicate devices listed (K082623 Televere Systems Visix Imaging; K061035 Televere Systems TigerView Professional) are also imaging management systems, reinforcing its non-diagnostic classification.
Yes
The device is described as a "software package" that runs on standard personal computers and interacts with drivers of imaging devices, not the devices themselves. It focuses on image acquisition, storage, organization, and processing within a software environment. While it relies on external hardware for image capture, the device itself is presented solely as software.
Based on the provided information, Improvis Imaging is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. The tests are performed outside of the body (in vitro).
- Improvis Imaging's Function: Improvis Imaging is a software package designed for acquiring, storing, organizing, and enhancing digital images and radiographs from dental imaging devices. It works with images captured from the patient, not on samples taken from the patient.
- Intended Use: The intended use is for managing and enhancing dental images for diagnostic purposes by trained dental professionals. This is distinct from performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any features related to analyzing biological samples, performing chemical or biological tests, or providing diagnostic results based on such tests.
Therefore, Improvis Imaging falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Improvis Imaging is a Windows-based software package that allows dental clinicians to acquire images from standard dental imaging devices and commercially available scanners, digital cameras and intra-oral cameras. It is designed to be used as an imaging database for storage and organization of patient digital images and radiographs. Features include resizing, rotating, embossing and sharpening of images.
Improvis Imaging is written using three programming languages (C++, C#, TSQL) and is designed to work with standard personal computers capable of running Windows 2000 or higher.
Intended users of this system are trained professionals, including but not limited to dentists, hygienists and clinical assistants.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Improvis Imaging is a software package that allows dental clinicians to acquire images from standard dental imaging devices and commercially available scanners, digital cameras and intraoral cameras. It is designed to be used as an imaging database for storage and organization of patient digital images and radiographs. Once acquired, images can be enhanced for viewing by applying image processing functions which include resizing, rotating, embossing and sharpening of images. All images are compressed using lossless compression and stored in a shared relational database.
The Improvis software interacts with the medical device software drivers, not the medical devices themselves. This interaction allows the computer system to acquire images captured via webcams, intraoral video cameras, panoramic x-rays, and other solid state sensors. These images are digitized by the outside vendor supplied medical devices, and then communicated via Improvis to the patient record. Once the images have been received by the system, they are embedded within the patient's dental record and can be accessed from any associated practice location.
Radiographic images are compressed via a lossless system and can be manipulated and enhanced to suit the dental care provider's needs. Non-diagnostic images, such as scanned documents, may be compressed using non-lossless methods which optimize image quality and storage requirements. Original compressed images are stored prior to application of any image processing algorithms.
Image processing by Improvis Imaging utilizes industry standard algorithms that do not result in the alteration of an image's or radiograph's content and will not introduce false data or modification into the acquired image. Improvis Imaging does not control the x-ray taking system and does not generate x-ray images directly from the physical device, but does provide the tools that permit the user to enhance images for diagnostic purposes.
Improvis Imaging is a three tier application consisting of user interface, business objects (which provide communication between the user interface and database tiers), and database. The top two tiers of the program are written in Microsoft Visual Studio .NET C#, while the database components are written in Microsoft T-SQL. Improvis Imaging is a Microsoft Windows Forms (non-browser based) 32 bit application designed to run on Windows-compatible personal computers running the Microsoft Windows XP (or higher) operating system. Imaging processing functions are provided through the integration of a third party software development toolkit from Lead Technologies, Inc.
Improvis Imaging is designed for use in a client-server environment in which the user interface portion of the application runs on an individual user's computer workstation as a Windows executable application. The Improvis Imaging shared database is installed on a single or clustered server running Microsoft SQL Server. The workstations and server are connected by a network using Microsoft Windows IP protocols. The application is designed for use in a Microsoft Windows Active Directory domain for authentication and access control, but can also run in non-Active Directory workgroups using internal Improvis access control.
Improvis Imaging is not compliant with DICOM standards.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dental imaging devices (standard), Scanners, Digital cameras, Intra-oral cameras. The software also interacts with medical device software drivers for webcams, intraoral video cameras, panoramic x-rays, and other solid state sensors.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals, including but not limited to dentists, hygienists and clinical assistants.
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)
Not Found
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).
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American Dental Partners, Inc. 401 Edgewater place Suite 430 Wakefield, MA 01880
MQW 1: 0 2010
510(k) Summary
IMPROVIS® Imaging System
The following information is presented as required by 21 C.F.R. § 807.92:
| Date Prepared: | September 29, 2010 |
|---|---|
| Submitter: | American Dental Partners, Inc. |
| 401 Edgewater Pl., Ste. 430 | |
| Wakefield, MA 01880-6225 | |
| Establishment | |
| Registration Number: | To be obtained |
| Manufacturing Site: | American Dental Partners, Inc. |
| 3000 Bethesda Place, Suite 501 | |
| Winston-Salem, NC 27103 | |
| Phone: 336-765-3900 | |
| Contact Person: | Timothy Rodenberger |
| General Counsel | |
| American Dental Partners, Inc. | |
| Tel: 781-213-0255 | |
| Fax: 781-224-4216 | |
| Email: TRodenberger@amdpi.com | |
| Device Trade Name: | IMPROVIS® Imaging System |
| Common Name: | Dental Imaging Software |
| Device Classification: | Picture Archiving and Communications System |
| Product Code: | LLZ |
| Regulation: | 21 C.F.R. § 892.2050 |
| Device Classification: | Class II |
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Predicate Devices:
| Televere Systems | Visix Imaging | K082623 |
|---|---|---|
| Televere Systems | TigerView Professional | K061035 |
Device Description
Improvis Imaging is a software package that allows dental clinicians to acquire images from standard dental imaging devices and commercially available scanners, digital cameras and intraoral cameras. It is designed to be used as an imaging database for storage and organization of patient digital images and radiographs. Once acquired, images can be enhanced for viewing by applying image processing functions which include resizing, rotating, embossing and sharpening of images. All images are compressed using lossless compression and stored in a shared relational database.
The Improvis software interacts with the medical device software drivers, not the medical devices themselves. This interaction allows the computer system to acquire images captured via webcams, intraoral video cameras, panoramic x-rays, and other solid state sensors. These images are digitized by the outside vendor supplied medical devices, and then communicated via Improvis to the patient record. Once the images have been received by the system, they are embedded within the patient's dental record and can be accessed from any associated practice location.
Radiographic images are compressed via a lossless system and can be manipulated and enhanced to suit the dental care provider's needs. Non-diagnostic images, such as scanned documents, may be compressed using non-lossless methods which optimize image quality and storage requirements. Original compressed images are stored prior to application of any image processing algorithms.
Image processing by Improvis Imaging utilizes industry standard algorithms that do not result in the alteration of an image's or radiograph's content and will not introduce false data or modification into the acquired image. Improvis Imaging does not control the x-ray taking system and does not generate x-ray images directly from the physical device, but does provide the tools that permit the user to enhance images for diagnostic purposes.
Improvis Imaging is a three tier application consisting of user interface, business objects (which provide communication between the user interface and database tiers), and database. The top two tiers of the program are written in Microsoft Visual Studio .NET C#, while the database components are written in Microsoft T-SQL. Improvis Imaging is a Microsoft Windows Forms (non-browser based) 32 bit application designed to run on Windows-compatible personal computers running the Microsoft Windows XP (or higher) operating system. Imaging processing functions are provided through the integration of a third party software development toolkit from Lead Technologies, Inc.
Improvis Imaging is designed for use in a client-server environment in which the user interface portion of the application runs on an individual user's computer workstation as a Windows
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executable application. The Improvis Imaging shared database is installed on a single or clustered server running Microsoft SQL Server. The workstations and server are connected by a network using Microsoft Windows IP protocols. The application is designed for use in a Microsoft Windows Active Directory domain for authentication and access control, but can also run in non-Active Directory workgroups using internal Improvis access control.
Improvis Imaging is not compliant with DICOM standards.
Intended Use
Improvis Imaging is a Windows-based software package that allows dental clinicians to acquire images from standard dental imaging devices and commercially available scanners, digital cameras and intra-oral cameras. It is designed to be used as an imaging database for storage and organization of patient digital images and radiographs. Features include resizing, rotating, embossing and sharpening of images. Intended users of this system are trained professionals, including but not limited to dentists, hygienists and clinical assistants.
Narrative Description of Substantial Equivalence:
The Improvis Imaging system is substantially equivalent to the predicate devices identified above. In particular, Improvis Imaging has the same intended use and similar technological features as the predicate devices. Like Visix Imaging and TigerView Professional, Improvis Imaging is a software application that supports the acquisition, viewing and editing of images and data from an imaging source. Images can be acquired from document scanners, intraoral video cameras, web cameras, digital cameras, and radiographic systems. Images are associated with patient records and presented using standard computer workstations and displays. The software is intended for use by dental professionals for diagnostic purposes, case documentation, and patient education. Users can overlay annotations on images, as well as calibrate and measure images. Methods such as brightness and contrast adjustment, sharpening, colorization, and reorientation are provided to allow images to be enhanced for optimal viewing. Images can also be printed and exported.
A comparison of the characteristics of the current device and the predicate devices is set forth in the charts below.
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Device Comparison
Table 1. Device Comparison
| Comparison Areas | IMPROVIS Imaging | Visix Imaging | TigerView Professional |
|---|---|---|---|
| Intended Use | Acquiring, viewing, editing and | ||
| storage of dental radiographs | |||
| and related patient image | |||
| records | Same | Same | |
| Intended Users | Trained dental professional | Same | Same |
| DICOM Compatible | No | Optional | Optional |
| Operating System | Microsoft Windows XP or higher | ||
| 32 and 64 bit OS | Microsoft Windows | ||
| 2000 or higher | |||
| 32 bit OS | Microsoft Windows 98 | ||
| or higher | |||
| 32 bit OS | |||
| Network | Ethernet IP 100 mbps or greater | Same | Same |
| Monitor | 800 x 600 or greater | 1024 x 768 or greater | 800 x 600 or greater |
| User Interaction/Input | Keyboard/Mouse | Same | Same |
| CPU | 2 GHz Pentium or higher | Same | Same |
| RAM | 1 GB or higher | Same | Same |
| Multi-User | Yes | Same | Same |
| Import/Export Images | Yes (BMP, TIFF, JPG) | Yes (TIFF, JPG) | Yes (TIFF, JPG) |
| Acquisition Devices | Sensor | ||
| Camera | |||
| Scanner | |||
| File Import | Same | Same | |
| Imaging Interfaces | Microsoft DirectX Version 9.0 | ||
| and higher | |||
| TWAIN 2.0 and higher | Proprietary | ||
| DirectX | |||
| TWAIN | Proprietary | ||
| DirectX | |||
| TWAIN | |||
| Image Organization | Create Series | ||
| Move Images | |||
| Create Series Template | Mount Images | ||
| Move within Mount | |||
| Create a Mount | Mount Images | ||
| Move within Mount | |||
| Create a Mount | |||
| Image Search Available | Yes | Same | Same |
| Image Storage | Original data unaltered | Original data unaltered | Original data unaltered |
| Lossless compression of | |||
| radiographic images | Lossless/lossy | ||
| compression | Lossless/lossy | ||
| compression | |||
| Full history of enhancements | |||
| recorded with each image | History of operations | History of operations | |
| Database Storage | Microsoft SQL Server database | File System | File System |
| Database Software | Microsoft SQL Server 2005 or | ||
| higher | File System | File System | |
| Comparison Areas | IMPROVIS Imaging | Visix Imaging | TigerView Professional |
| Image Viewing | Zoom In and Out | Zoom In and Out | Zoom In and Out |
| Full Screen | Full Screen | Full Screen | |
| Scale to 100% | Reset Zoom | Reset Zoom | |
| Rotate 90 or 180 degrees | Rotate 90° or 180° | Rotate 90° or 180° | |
| Flip Left to Right | Flip Left to Right | Flip Left to Right | |
| Flip Top to Bottom | Flip Top to Bottom | Flip Top to Bottom | |
| Rotate 0 Degrees | Reset Orientation | Reset Orientation | |
| Image Measurement | Line | Line | Line |
| Angle | Angle | Angle | |
| Calibrate | Calibrate | Calibrate | |
| Line Color | |||
| Show/Hide | Line Color | ||
| Show/Hide | Line Color | ||
| Show/Hide | |||
| Image Annotation | Line | Line | Line |
| Free Line | Freehand | Freehand | |
| Circle | Circle | Circle | |
| Rectangle | Square | Square | |
| Arrows | Arrows | Arrows | |
| Text | Text | Text | |
| Color | Color | Color | |
| Width | Width | Width | |
| Show/Hide | Show/Hide | Show/Hide | |
| Image Operations | Magnifier | Magnifying Glass | Magnifying Glass |
| Negative | Negate | Negate | |
| Colorize | Colorize | Colorize | |
| Emboss | Pseudo 3D | Pseudo 3D | |
| Sharpen | Sharpen Edge | Sharpen Edge | |
| Original Image | Original Image | Original Image | |
| Brightness | Brightness | Brightness | |
| Contrast | Contrast | Contrast | |
| Gamma | Gray Shift (Gamma) | Gray Shift (Gamma) | |
| Security | Login, admin, and feature access | Login and admin | Login and admin |
ﺮ ﺍ
4
and the comments of the comments of the comments of
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Image /page/5/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
American Dental Partners, Inc. % Mr. Timothy Rodenberger General Counsel 401 Edgewater Place, Suite 430 WAKEFIELD MA 01880-6225
NOV 1 0 2010
Re: K101654 Trade/Device Name: Improvis® Imaging System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 29, 2010 Received: September 29, 2010
Dear Mr. Rodenberger:
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
6
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,
Dan
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K101654
NOV 1 0 2010
Device Name: Improvis® Imaging System
Indications for Use:
Improvis Imaging is a Windows-based software package that allows dental clinicians to acquire images from standard dental imaging devices and commercially available scanners, digital cameras and intra-oral cameras. It is designed to be used as an imaging database for storage and organization of patient digital images and radiographs. Features include resizing, rotating, embossing and sharpening of images.
Improvis Imaging is written using three programming languages (C++, C#, TSQL) and is designed to work with standard personal computers capable of running Windows 2000 or higher.
Intended users of this system are trained professionals, including but not limited to dentists, hygienists and clinical assistants.
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)
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