RAMSOFT PACS, MODEL 3.0

K031562 · Ramsoft, Inc. · LLZ · Aug 11, 2003 · Radiology

Device Facts

• Record ID: K031562
• Device Name: RAMSOFT PACS, MODEL 3.0
• Applicant: Ramsoft, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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, 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.

Device Story

RamSoft PACS is a stand-alone software package operating on general-purpose computing hardware. It functions as a Picture Archiving and Communication System (PACS) to acquire, transmit, store, and display medical images. Inputs include digital images from modalities like CR, CT, DX, MR, NM, PT, RF, US, and XA, as well as video captures, film digitizing, and document scanning. The system utilizes a network (TCP/IP) to manage data between image servers, web servers, and workstations. Physicians use the software for clinical review, interpretation, and quality control. Features include image measurement, cine tools, comparison modes, MPR, MIR, and annotation. The system provides clinicians with tools to manipulate and view images, facilitating diagnostic decision-making. It is intended for use in clinical environments where a physician provides human intervention during image interpretation.

Clinical Evidence

Bench testing only. No clinical data provided. The device was tested according to a documented System Test Plan as part of the software development process.

Technological Characteristics

Stand-alone software for general-purpose computing hardware. Supports DICOM 3.0, Bitmap, JPEG, TIFF, and TWAIN inputs. Network protocol: TCP/IP. Compression methods: JPEG, RLE. Features include MPR, MIR, image measurement, cine tools, and annotation. Software level of concern: minor.

Indications for Use

Indicated for clinical image acquisition, transmission, storage, and display for diagnostic interpretation and review. Used by clinicians in radiology and other clinical settings. No specific age or gender restrictions.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• RamSoft Ultrapro 98 (K982563)
• Kodak AutoRad (K955092)
• GE Advantage (K94120)

Submission Summary (Full Text)

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Tel: [phone] Fax: [phone] E-mail: [e-mail]

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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

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K031542
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# Comparison to Predicate Devices

| Product Name | GE Advantage<br>Windows (K942120) | Kodak AutoRad<br>(K955092) | RamSoft Ultrapro 98<br>K982563 | RamSoft PACS<br>(this<br>submission) |
|-----------------------------------------------------|-----------------------------------|----------------------------|--------------------------------|--------------------------------------|
| Print to paper | Yes | Yes | Yes | Yes |
| Graphical UI | Yes | Yes | Yes | Yes |
| Windows OS | Yes | Yes | Yes | Yes |
| Uses<br>standard<br>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<br>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<br>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<br>inside and outside<br>radiology | Yes | Yes | Yes | Yes |
| | | | | |
| Flip/Rotate images | Yes | Yes | Yes | Yes |
| User Log in | Yes | Yes | Yes | Yes |
| Multiple<br>layout<br>options | Yes | Yes | Yes | Yes |
| Window<br>control<br>and presets | Yes | Yes | Yes | Yes |
| | | | | |
| Patient and Study<br>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."

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May 16, 2003

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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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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