(84 days)
Not Found
No
The document describes a standard PACS system for image management and display, with no mention of AI or ML capabilities. The focus is on image processing, storage, and communication.
No
The device is a software package for acquiring, transmitting, storing, and displaying medical images; it does not directly treat or diagnose a disease or condition.
No
Explanation: The device is a PACS software system used for acquiring, transmitting, storing, and displaying images for clinical purposes. While it is used with clinical images, its primary function is image management and review, not providing a diagnosis based on analysis of the images. Interpretation is done by a physician.
Yes
The device is described as a "stand-alone software package" that runs on "general purpose computing hardware." While it interacts with imaging devices and displays images, the core medical device functionality is explicitly stated to be the software itself, with the hardware being a separate component chosen by the user or system integrator.
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.
- RamSoft PACS function: The description clearly states that RamSoft PACS is used to "acquire, transmit, store and display images for clinical purposes." These images are acquired from imaging devices like CR, CT, MR, etc., which are used to visualize structures within the body, not to analyze samples from the body.
- Lack of mention of biological samples: There is no mention of analyzing blood, urine, tissue, or any other biological sample.
Therefore, RamSoft PACS falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
RamSoft PACS software is used with general purpose computing hardware to acquire, transmit, store and display images for clinical purposes. RamSoft PACS consists of one or more of image server, web server, and workstations for interpretation, dinical review, quality control, video capturing, film digitizing, document scanning. Images may be acquired from imaging devices such as CR, CT, DX, MR, NM, PT, RF, US, XA, and other devices.
Product codes
LLZ
Device Description
RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform.
The software allows digital image processing, measurement, communication, and storage.
RamSoft PACS is tested according to the specifications that are documented in a RamSoft PACS System Test Plan. Testing is an integral part of RamSoft's software development process.
The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, CT, DX, MR, NM, PT, RF, US, XA, and other devices.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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).
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Tel: (416) 674-1347 Fax: (416) 674-7147 E-mail: sales@ramsoft.biz
Image /page/0/Picture/2 description: The image shows a logo with the word "RAMSOFT" inside a circle. The circle is surrounded by a design that looks like two curved shapes. The logo is black and white and has a simple design.
uanian mu 16 Four Seasons Place, Unit 215 Toronto, ON M9B 6E5 CANADA Web Site: http://www.ramsoft.biz
510(k) Summary
Contact Name: Lucian Popescu, QA Manager Trade Name - RamSoft PACS Common Name - Picture Archiving and Communication System (PACS) Classification Name - LLZ - Image Processing System (892.2050)
Substantially Equivalent devices:
Ultrapro 98 (RamSoft Inc) - K982563
Kodak AutoRad (Kodak) - K955092
GE Advantage (General Electric Medical Systems) - K94120
Description:
RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform.
The software allows digital image processing, measurement, communication, and storage.
RamSoft PACS is tested according to the specifications that are documented in a RamSoft PACS System Test Plan. Testing is an integral part of RamSoft's software development process.
The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.
Intended Use:
RamSoft PACS software is used with general purpose computing hardware to acquire, transmit, store and display images for clinical purposes. RamSoft PACS consists of one or more of image server, web server, and workstations for interpretation, dinical review, quality control, video capturing, film digitizing, document scanning. Images may be acquired from imaging devices such as CR, CT, DX, MR, NM, PT, RF, US, XA, and other devices.
PD0003
RAMSO
1
K031542
Page 2 of 2
Image /page/1/Picture/1 description: The image shows a close-up of a horseshoe. The horseshoe is made of metal and has a curved shape. The horseshoe appears to be old and worn, with some rust and discoloration. The background is blurred, which helps to focus attention on the horseshoe.
Comparison to Predicate Devices
| Product Name | GE Advantage
Windows (K942120) | Kodak AutoRad
(K955092) | RamSoft Ultrapro 98
K982563 | RamSoft PACS
(this
submission) |
|-----------------------------------------------------|-----------------------------------|----------------------------|--------------------------------|--------------------------------------|
| Print to paper | Yes | Yes | Yes | Yes |
| Graphical UI | Yes | Yes | Yes | Yes |
| Windows OS | Yes | Yes | Yes | Yes |
| Uses
standard
displays | Yes | Yes | Yes | Yes |
| Image input | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| | | | Bitmap | Bitmap |
| | | | JPEG | JPEG |
| | | | TIFF | TIFF |
| | | | Film | Film |
| | | | Video | Video |
| | | | TWAIN | TWAIN |
| Images stored on
remote NT server | Yes | Yes | Yes | Yes |
| Network protocol | TCP/IP | TCP/IP | TCP/IP | TCP/IP |
| Compression | Wavelet | JPEG | JPEG | JPEG |
| | | | RLE | RLE |
| Annotation | Yes | Yes | Yes | Yes |
| Image
Measurement | Yes | No | Yes | Yes |
| | | | | |
| Cine tool | Yes | Yes | Yes | Yes |
| Comparison Mode | Yes | Yes | Yes | Yes |
| Review RIS Report | Yes | Yes | Yes | Yes |
| Designed for use
inside and outside
radiology | Yes | Yes | Yes | Yes |
| | | | | |
| Flip/Rotate images | Yes | Yes | Yes | Yes |
| User Log in | Yes | Yes | Yes | Yes |
| Multiple
layout
options | Yes | Yes | Yes | Yes |
| Window
control
and presets | Yes | Yes | Yes | Yes |
| | | | | |
| Patient and Study
Browser | Yes | Yes | Yes | Yes |
| | | | | |
| MPR | Yes | No | No | Yes |
| MIR | Yes | No | No | Yes |
Conclusion
In conclusion, RamSoft PACS is substantially equivalent to RamSoft Ultrapro 98, GE Advantage, and Kodak AutoRad. The determination of substantial equivalence is not based on an assessment of performance tests. It is our conclusion that there is no software component in RamSoft PACS product or hardware component which would be used in conjunction with RamSoft PACS product that we know of whose failure or latent design flaw would be expected to result in death or injury to a patient. Thus, the "Level of Concern" of RamSoft PACS product is "minor."
Image /page/1/Picture/6 description: The image shows the word "RAMSOFT" in large, bold, black letters. Above the word "RAMSOFT" is the text "PD0003" in a smaller font size. There is a horizontal line above the text "PD0003".
May 16, 2003
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Image /page/2/Picture/1 description: The image shows a logo with a stylized bird in the center. The bird is depicted with three curved lines forming its body and wings, giving it a sense of motion. Encircling the bird is text, arranged in a circular fashion around the bird. The text appears to be in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2003
Mr. Lucian Popescu QA Manager RamSoft, Inc. 215-16 Four Seasons Place Toronto, ON M9B 6E5 CANADA
Re: K031562 Trade/Device Name: RamSoft PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: May 16, 2003 Received: May 21, 2003
Dear Mr. Popescu:
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 (PMA). it may be subject to 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.
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.
3
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
510(k) Number (if known):
510(k) Number (if known): K031562
Device Name: RamSoft PACS
Indications for Use:
RamSoft PACS software is used with general purpose computing hardware to acquire, transmit, store and display images for clinical purposes. RamSoft PACS consists of one or more of image server, web server, database server, and workstations for interpretation, clinical review, quality control, video capturing, film digitizing, document scanning. Images may be acquired from imaging devices such as CR, CT, DX, MR, NM, PT, RF, US, XA, and other devices.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use
Over-The-Counter Use -OR-
David G. Bergman
ivision Sign-Off Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number