(15 days)
Not Found
No
The description focuses on standard image management and processing functionalities, with no mention of AI or ML terms or capabilities.
No
This device is an image management system used by dentists to acquire, archive, display, and manage digital images, without any indication of providing treatment or therapy.
No.
The device is described as an image management system for acquiring, archiving, displaying, editing, printing, emailing, and importing/exporting digital images, which are functions of image management, not diagnosis.
Yes
The device is described as "PatientGallery Imaging Software" and its description focuses solely on its software functionalities for managing digital images. While it interfaces with hardware for image acquisition, the device itself is presented as a software system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on managing digital images for dentists, including acquisition, archiving, display, editing, printing, emailing, and importing/exporting. This is related to image management and workflow within a dental practice.
- Device Description: The description reinforces the image management function, describing it as a database system for organizing and handling various types of dental images.
- Lack of Diagnostic Purpose: There is no mention of the device being used to perform tests on samples taken from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are specifically designed for these types of in vitro analyses.
- Input Modalities: The input modalities (x-ray sensors, intra-oral cameras, digital cameras, flatbed scanners) are all related to capturing images of the patient or their dental structures, not analyzing biological samples.
The device is clearly an image management system for dental practices, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
PatientGallery Imaging Software will be used primarily by Dentists for the indications of acquiring, archiving, displaying, editing, printing, emailing, and importing or exporting digital images.
PatientGallery is a Windows-based image management system indicated for use primarily by dentists to acquire, archive, display, edit, print, email, and import/export digital images.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
PatientGallery Imaging Software is a Windows-based image management database, or system used primarily by Dentists for the indications of acquiring, archiving, displaying, editing, printing, emailing, and importing or exporting digital images.
The database is organized like a file cabinet by patient folder accommodates grayscale and color images which may also include textual and graphic notes and annotations. Images may be assembled into layouts which can be customized as required. Optional modules provide editing and viewing functions.
Image acquisition from x-ray sensors, intra-oral video cameras, digital cameras and flatbed scanners can be distributed among several workstations. The software provides direct interfaces to many industry standard devices through OEM toolkits. PatientGallery Imaging Software uses standard Windows peer-to-peer networking. By default, images are stored in the native format provided by the hardware manufacturers. PatientGallery Imaging Software may be invoked by other practice management applications so that specific patient information is accessed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray sensors, intra-oral video cameras, digital cameras and flatbed scanners
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists
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)
A Hazard Analysis was performed for the PatientGallery Imaging Software, which led to the development of Software Requirement Specifications (SRS). The SRS was used to develop a Verification & Validation (V&V) plan executed through a series of Test Cases. The V&V testing was passed, demonstrating that the PatientGallery Imaging Software performs as indicated.
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
510(k) SUMMARY
General Information
| Submitted by: | Raster Builders, Inc.
650 South Eliseo Drive
Greenbrae, CA 94904 | APR 20 2007 |
|-----------------|------------------------------------------------------------------------|-------------|
| | Phone: (800) 925-2134 | |
| Contact Person: | Eric Chasanoff
650 South Eliseo Drive
Greenbrae, CA 94904 | |
| | Phone: (800) 925-2134 | |
| Date Prepared: | February 23, 2007 | |
Device Information
| Trade Name: | PatientGallery Imaging Software |
|---|---|
| Common Name: | Picture archiving and communications system |
| Classification: | Class II |
| Classification Name: | System, Image Processing, Radiological |
| Reference: | 21 CFR 892.2050 |
Predicate Device
| Manufacturer
| 510(k) No. | Product Name |
|---|---|
| Televere Systems | |
| K061035 | TigerView Professional |
Device Description
PatientGallery Imaging Software is a Windows-based image management database, or system used primarily by Dentists for the indications of acquiring, archiving, displaying, editing, printing, emailing, and importing or exporting digital images.
The database is organized like a file cabinet by patient folder accommodates grayscale and color images which may also include textual and graphic notes and annotations. Images may be assembled into layouts which can be customized as required. Optional modules provide editing and viewing functions.
1
Image acquisition from x-ray sensors, intra-oral video cameras, digital cameras and flatbed scanners can be distributed among several workstations. The software provides direct interfaces to many industry standard devices through OEM toolkits. PatientGallery Imaging Software uses standard Windows peer-to-peer networking. By default, images are stored in the native format provided by the hardware manufacturers. PatientGallery Imaging Software may be invoked by other practice management applications so that specific patient information is accessed.
Intended Use
PatientGallery Imaging Software will be used primarily by Dentists for the indications of acquiring, archiving, displaying, editing, printing, emailing, and importing or exporting digital images.
Safety Information
A Hazard Analysis was performed for the PatientGallery Imaging Software, which led to the development of Software Requirement Specifications (SRS). The SRS was used to develop a Verification & Validation (V&V) plan executed through a series of Test Cases. The V&V testing was passed, demonstrating that the PatientGallery Imaging Software performs as indicated.
Conclusion
The information contained in this Pre-market Notification is sufficient to demonstrate that the PatientGallery Imaging Software functions as described, and is substantially equivalent to the TigerView Professional software manufactured by Televere Systems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Raster Builders, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131
APR 2 0 2007
Re: K070954
Trade/Device Name: Patient Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 4, 2007 Received: April 5, 2007
Dear Mr. Christensen:
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 either class II (Special Controls) or class III (Premarket Approval), 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.
Image /page/2/Picture/9 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the letters "FDA" in a stylized font. The word "Centennial" is written in cursive below the letters. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.
Protesting and Promoting Public Health
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Page 2 -
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 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 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 | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: None KO70954
Name of Device: PatientGallery Imaging Software
Indications for Use:
PatientGallery is a Windows-based image management system indicated for use primarily by dentists to acquire, archive, display, edit, print, email, and import/export digital images.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF . NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deith. leym
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070954
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