(52 days)
Not Found
No
The description focuses on standard image management and editing functions within a PACS environment, with no mention of AI, ML, or related concepts like deep learning, neural networks, or automated analysis beyond basic image manipulation.
No
The device is described as an image management system and clinical software application for acquiring, displaying, editing, reviewing, storing, printing, and distributing images and data. It does not exert any action on the body or directly treat any condition; its function is purely for data and image management.
No
The device is described as a clinical software application and image management system that receives, stores, displays, edits, and distributes images and data. It does not mention analysis or interpretation of images for the purpose of diagnosis.
Yes
The device is described as a "clinical software application" and an "image management system" that runs on "standard PC-compatible computers" and is compatible with various capture devices. While it interacts with hardware for image acquisition and display, the device itself is the software component performing the image management and processing functions. The description focuses on the software's capabilities and does not indicate the device includes any proprietary or specialized hardware components beyond standard PC hardware and capture devices.
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.
- TigerView Professional's Function: TigerView Professional is described as a clinical software application that manages and processes medical images from various imaging sources (radiographic devices, digital video capture, scanners). It focuses on acquiring, displaying, editing, storing, and distributing these images.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples. Its function is centered around the management and manipulation of medical images.
Therefore, TigerView Professional falls under the category of medical image management and processing software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TigerView Professional 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). In addition, TigerView Professional enables the storage of clinical notes, audio recordings, and clinical exam data.
It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, annotate, etc.), review, store, print, and distribute images using standard PC hardware.
Product codes
LLZ
Device Description
TigerView Professional is an image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, 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 / PACS environment
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)
TigerView Professional has been demonstrated to perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Kob/035
Televere Systems TigerView Professional Section 5.0, 510(k) Summary 510(k) Premarket Notification
.
Page 1 of 2
510(k) SUMMARY
General Information
JUN - 5 2006
| Submitted by: | Televere Systems |
|---|---|
| 16275 South Monterey Road, Suite K | |
| Morgan Hill, CA 95037 | |
| Phone: 408.778.1700 | |
| Fax: 408.778.1733 | |
| Contact Person: | Mr. Randell Quaal |
| 16275 South Monterey Road, Suite K | |
| Morgan Hill, CA 95037 | |
| Phone: 408.778.1700 | |
| Fax: 408.778.1733 | |
| Email: rquaal@tigerview.com | |
| Date Prepared: | April 14, 2006 |
Device Name
| Trade Name: | TigerView Professional |
|---|---|
| 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. |
|---|---|---|
| EagleSoft, A Patterson Co. | EagleSoft ChairSide Software | |
| Application | K982422 | |
| Tau Corp. | TigerScan/TigerView | K955237 |
1
Device Description
TigerView Professional is an image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card.
Intended Use
TigerView Professional 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). In addition, TigerView Professional enables the storage of clinical notes, audio recordings, and clinical exam data.
It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, annotate, etc.), review, store, print, and distribute images using standard PC hardware.
Technological Comparison
TigerView Professional, TigerScan/TigerView, 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
TigerView Professional has been demonstrated to perform as intended.
Conclusions
Tiger View Professional is substantially equivalent to legally marketed Image Processing Systems (i.e. PACS).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the caduceus symbol.
JUN - 5 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Televere Systems % Ms. Melissa Mahall Director, Regulatory Affairs Bio-Reg Associates, Inc. 6304 Belmont Circle, Bldg 2 MOUNT AIRY MD 21771
Re: K061035
Trade/Device Name: TigerView Professional Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 14, 2006 Received: April 14, 2006
Dear Ms. Mahall:
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/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" in bold letters. The logo is surrounded by text that reads "Dedicated to the science of sound nutrition". The logo appears to be a commemorative emblem for the FDA's centennial anniversary.
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 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Nancy C. Brogdon
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
Kol 1035 510(k) Number (if known):
7
TigerView Professional
Sponsor Name:
Televere Systems
Indications for Use:
Device Name:
TigerView Professional 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). In addition, TigerView Professional enables the storage of clinical notes, audio recordings, and clinical exam data.
It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, annotate, etc.), review, store, print, and distribute images using standard PC hardware.
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)
David A. Leggion
n of Reproductive. Abdomina adiological Devic