(75 days)
Not Found
No
The document describes a system for acquiring, displaying, communicating, and archiving medical images with standard image processing features like compression, display adjustments, annotations, and measurements. There is no mention of AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data.
No
The device is described as a system for acquiring, displaying, communicating, and archiving diagnostic images, and is a tool for medical imaging practice, not a therapeutic intervention.
No
The device is described as a system that acquires, displays, communicates, and archives diagnostic images. It does not perform diagnostic functions itself but rather handles existing diagnostic images. The Intended Use section states it is "to acquire data from FDA listed imaging equipment such as ultrasound, CT and MRJ scanners, x-ray imagers and video cassette recorders that provide a video output or a digital output," indicating it processes data from other diagnostic devices.
No
The device description explicitly states that Ultrapro "utilizes standard personal computer hardware" and is a "tool for a medical imaging practice" that can acquire images from "any standard medical video source" and digital data. While the core functionality is software-based (image acquisition, display, communication, archiving, processing), it is described as a system that uses hardware, not solely 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 system is designed to acquire, display, communicate, and archive diagnostic images from FDA listed imaging equipment (ultrasound, CT, MRI, x-ray, VCRs). It is used by medical professionals to manage and review these images.
- Device Description: The description reinforces this by detailing how it acquires, stores, displays, and communicates medical images and related patient information.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not interact with biological specimens or perform any analysis on them. It deals with images generated by other diagnostic equipment.
The device is a medical image management and archiving system, which falls under a different regulatory category than IVD devices. The predicate devices listed (PACS and Archive Manager systems) further support this classification.
N/A
Intended Use / Indications for Use
Ultrapro is a system that utilizes standard personal computer hardware to acquire, display, communicate and archive diagnostic images. The system is designed for use by medical professionals to acquire data from FDA listed imaging equipment such as ultrasound, CT and MRI scanners, x-ray imagers and video cassette recorders that provide a video output or a digital output. Archival is to be performed on media that is FDA listed.
Ultrapro can be configured to use JPEG lossy compression. When lossy compression is used, the compression ratio will be imprinted in the non-diagnostic area of the image. The compression ratio can be adjusted during acquisition.
Product codes (comma separated list FDA assigned to the subject device)
892.2020 LMD, 90 LLZ
Device Description
Ultrapro is a tool for a medical imaging practice. It can acquire medical images from any standard medical video source. Digital data in the DICOM format or other popular PC formats such as JPEG, TIFF, etc. can also be acquired.
Images may be acquired in uncompressed or compressed format (lossless or lossy). The lossy compression ratio is selected by viewing the original image and the lossy compressed image side by side and increasing the ratio while retaining clinically significant characteristics. Images that have been lossy compressed have the text "LOSSY xx:1" where xx is the compression ratio placed in the visible, non-diagnostic area of the image.
Related patient information can also be entered or scanned in with a TWAIN compliant scanner. Once acquired, Ultrapro serves as a digital storage for these images. Images are stored on the computer. Images may be communicated to other Ultrapro workstations or to third-party DICOM 3.0 compliant PACS components. The radiologist may review the images with Ultrapro and create reports. The display of images (contrast, brightness, zoom, etc.) may be adjusted at any time. Annotations may be drawn on images. Distance measurements may be made on images. These image parameters may be saved along with the image while still preserving the original image. This information can be communicated to other workstations through a network or modem. Finally, all of the information may be archived onto optical media for permanent storage.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Multi-modality (ultrasound, CT, MRI, x-ray imagers, video cassette recorders)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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.
ALI UltraPACS (K925965/A), CEMAX-ICON Archive Manager 2.0 and Autorad modules (K955092)
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
Image /page/0/Picture/0 description: The image shows a logo on the left and a date on the right. The logo is circular and contains the text "RamSoft". The date is "OCT 6 1998". The text is in a bold, sans-serif font.
K982 56.3
510(k) Summary for Ultrapro 98 1
1.1 General Information
1.1.1 Name and Address of Manufacturer
RamSoft Inc. 37 Bankview Circle Toronto. ON M9W 6S6, CANADA Tel: (416) 674-1347 Fax: (416) 674-7147 Email: ram@ramsoft.on.ca Contact Person: Naganatha S Ramanathan
1.1.2 Establishment Registration Number
9006410
1.1.3 Common and Proprietary names of Device
Trade or Proprietary Name: Ultrapro™ Common Name: Picture Archiving and Communication System
1.1.4 Class
Systems, digital image communications - Class | 892.2020 LMD
12 Substantially Equivalent Devices
ALI UltraPACS (K925965/A) with ALI comPACS data compression module (K963610) Manufactured by: ALI Technologies, Inc
CEMAX-ICON Archive Manager 2.0 and Autorad modules (K955092) Manufactured by: CEMAX-ICON Inc.
1.3 Device Description
Ultrapro is a tool for a medical imaging practice. It can acquire medical images from any standard medical video source. Digital data in the DICOM format or other popular PC formats such as JPEG, TIFF, etc. can also be acquired.
Images may be acquired in uncompressed or compressed format (lossless or lossy). The lossy compression ratio is selected by viewing the original image and the lossy compressed image side by side and increasing the ratio while retaining clinically significant characteristics. Images that have been lossy compressed have the text "LOSSY xx:1" where xx is the compression ratio placed in the visible, non-diagnostic area of the image.
Related patient information can also be entered or scanned in with a TWAIN compliant scanner. Once acquired, Ultrapro serves as a digital storage for these images. Images are stored on the computer. Images may be communicated to other Ultrapro workstations or to third-party DICOM 3.0 compliant PACS components. The radiologist may review the images with Ultrapro and create reports. The display of images (contrast, brightness, zoom, etc.) may be adjusted at any time. Annotations may be drawn on images. Distance measurements may be made on images. These image parameters may be saved along with the image while still preserving the original image. This information can be communicated to other workstations through a network or modem. Finally, all of the information may be archived onto optical media for permanent storage.
1
Image /page/1/Picture/0 description: The image shows a logo for a company called "RalliSoft". The logo features the company name in a stylized font inside of an oval shape. The oval is positioned in the center of a globe graphic. The globe is depicted with curved lines to represent the continents and oceans.
1.4 Intended Use Statement
Ultrapro is a system that utilizes standard personal computer hardware to acquire, display, communicate and archive diagnostic images. The system is designed for use with FDA approved imaging equipment that provides a video output or a digital output.
| ALI UltraPACS with ALI comPACS | RamSoft Ultrapro | |
|---|---|---|
| Image Acquisition | Video frame grabber or DICOM | |
| input | Video frame grabber, FDA | |
| approved film scanner or DICOM | ||
| input | ||
| Compatible Video Signals | NTSC (up to 30 frames/s, | |
| 640x480, 256 grayscale, 16.7 | ||
| million colors) | ||
| PAL (up to 25 frames/s, 768x576. | ||
| 256 grayscale, 16.7 million colors) | NTSC (up to 30 frames/s, | |
| 640x480, 256 grayscale, 16.7 | ||
| million colors) | ||
| PAL (up to 25 frames/s, 768x576, | ||
| 256 grayscale, 16.7 million colors) | ||
| Cine Capability (motion capture) | Yes | Yes |
| Image Compression | Lossless RLE and Lossy JPEG | Lossless RLE and Lossy JPEG |
| Lossy Compression Ratio | ||
| Range | 4:1 to 30:1 | 4:1 to 60:1 |
| Uses JPEG lossy compression | ||
| in viewing, transmitting and | ||
| archiving still images | Yes | Yes |
| Uses Motion JPEG lossy | ||
| compression for viewing, | ||
| transmitting and archiving cine | ||
| images | Yes | Yes |
| DICOM 3.0 compliant | Yes | Yes |
| Imaging Modalities | Multi-modality | Multi-modality |
| Image Display Capability | Yes | Yes |
| Remote and Local Area Network | ||
| Communication | Yes | Yes |
| Image Annotation Capability | Yes | Yes |
| Archives Image on Optical | ||
| Media | Yes | Yes |
1.5 Companson of Technological Characteristics
1.6 Conclusion
In conclusion, Ultrapro is substantially equivalentitititi to the ALI product. The determination of substantial equivalence is not based on an assessment of performance tests.
ﺎ
55555 : 35453 :
2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with its wings spread, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 1998
Naganatha S. Ramanathan, Ph.D. President Ramsoft, Inc. 37 Bankview Circle Toronto, Ontario Canada M9W 6S6
Re:
K982563 "Ultrapro 98, Digital Image Communications System Dated: July 22, 1998 Received: July 23, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Dr. Ramanathan:
We have reviewed your Section 5100% notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments on to devices that have been reclassified in accordance with the Feceral Food Drues and Cosmetic Act (Act). You may, therefore, narket the device, subject to the general controls of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical-Devices: Generaliation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition; FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odch/dsmamain.html"
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and -Radiological Health
Enclosure
3
Page of
t
| 510(k) Number (if known): | K982563 |
|---|---|
| Device Name: | ULTRAPRO 98 |
Indicatic is For Use:
Ultrapro is a system that utilizes standard personal computer hardware to acquire, display, communicate and archive diagnostic images. The system is designed for use by medical professionals to acquire data from FDA listed imaging equipment such as ultrasound, CT and MRJ scanners, x-ray imagers and video cassette recorders that provide a video output or a digital output. Archival is to be performed on media that is FDA listed.
Ultrapro can be configured to use JPEG lossy compression. When lossy compression is used, the compression ratio will be imprinted in the non-diagnostic area of the image. The compression ratio can be adjusted during acquisition.
(PL) ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gimel li. Syson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)