AETMED IMAGE PROCESSING SOFTWARE

K012093 · Aetmed, S.P.A. · LLZ · Sep 21, 2001 · Radiology

Device Facts

• Record ID: K012093
• Device Name: AETMED IMAGE PROCESSING SOFTWARE
• Applicant: Aetmed, S.P.A.
• Product Code: LLZ · Radiology
• Decision Date: Sep 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies.

Device Story

AETmed Medical Image Processing Software is a software-based system for medical image management. It operates on standard PC hardware running Windows NT or 2000. The system ingests medical images via DICOM-compliant interfaces and analog video signals (525, 625, 1023, 1049, 1249 lines; interlaced or progressive). It provides tools for image acquisition, archiving (CD-R, MOD, DVD, DLT), and review (still images, cine-loops, window/level, zoom, magnification). Processing capabilities include annotations, distance/angle measurements, pixel statistics, Quantitative Coronary Analysis, Left Ventricle Analysis, and 3D processing (MPR, MIP, volume rendering). Used in clinical settings by medical professionals, the software facilitates diagnostic review and workflow management. Output is displayed on high-resolution monitors to assist clinicians in evaluating cardiac and radiological studies, supporting clinical decision-making through enhanced visualization and quantitative analysis.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technical comparison of features, performance specifications, and intended use.

Technological Characteristics

Software-based image processing system for PC platforms (Windows NT/2000). Supports DICOM-compliant image communication and TCP/IP networking. Features include 8-bit to 24-bit color depth, display resolutions up to 2048x2560, and multi-monitor support. Image processing includes 2D/3D tools (MPR, MIP, volume rendering) and quantitative analysis modules. Analog video input support for various line formats (525-1249) at <= 30 fps. Archiving via DICOM-compatible removable media.

Indications for Use

Indicated for use by qualified medical professionals for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, including cardiac catheterization, echocardiography, and general radiological studies.

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

• Electromed View NT (K000474)
• Applicare Radworks Medical Imaging Software with Quality Control Module (K982862)
• Cemax-Icon Accurad Image management System (K955092)

Submission Summary (Full Text)

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K012093

## 510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

807.92(a)(1)

### Submitter Information

AETmed, S.p.A. Viale Cembrano, 4C 16148 Genova, Italy Phone: [phone] 390103070937 Facsimile: Contact Person: Massimiliano Peri April 30, 2001 Date: 807.92(a)(2) Trade Name: AETmed Image Processing Software Common Name: Image Processing Software Classification Name(s): System, Image Processing Classification Number: LLZ 807.92(a)(3) Predicate Device(s) Electromed View NT K000474 Applicare Radworks Medical Imaging K982862 Software with Quality Control Module Cemax-Icon Accurad Image management System; K955092

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

AutoRad Regustr

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807.92(a)(4)

#### Device Description

The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and mard ware planeral, tor cardiac cathererization, echocardiography, and general radiological studies.

The Version 3.0 DICOMed Family Software System consists of the following components:

- DICOMed DIG.IT image acquisition and CD recording station o
- DICOMed P@CS image archiving manager o
- DICOMed Review Cardio review workstation for cardiology o
- DICOMed Review diagnostic review workstation for radiology o

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807.92(a)(5)

## Intended Use(s)

The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies.

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| Feature | Product | AETmed Image<br>Processing software<br>(This submission) | VIEW NTTM | Radworks Medical<br>Imaging Software<br>with Quality Control<br>Module | Accurad Image<br>Management System,<br>AutoRad Regustr |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Manufacturer | AETmed | Electromed | Applicare | Cemax Icon | |
| 510(k) Number | K000474 | K982862 | K955092 | | |
| Classification | 892.2050; Class II | 892.2050; Class II | 892.2050; Class II | 892.2050; Class II | |
| Intended Use | The AETmed Medical<br>image processing<br>Software is a software<br>device intended to be<br>used by qualified<br>medical professionals,<br>after proper installation<br>on an appropriate<br>hardware platform, for<br>capturing, retrieving,<br>viewing, processing,<br>printing, archiving, and<br>communicating<br>medical images, such<br>as cardiac<br>catheterisation, echo-<br>cardiography, and<br>general radiological<br>studies. | VIEW NT is a<br>powerful real-time<br>cardiac image<br>acquisition, display,<br>processing and<br>communication system<br>enhancing the<br>performance of a<br>Cathlab and its<br>connection to the<br>Digital Image<br>Archiving network.<br>Both Quantitative<br>Coronary Analysis and<br>Ventricular Analysis<br>Software's are included<br>with the VIEW NT. | The RadWorks<br>Medical Imaging<br>Software, from<br>Applicare Medical<br>Imaging, B.V., when<br>installed on an<br>appropriate hardware<br>platform, is intended to<br>provide capability for<br>the acceptance, display,<br>storage, and digital<br>processing of medical<br>images. Options allow<br>for additional<br>capability, including<br>transmission of images<br>over local area<br>networks or public<br>communications<br>channels, digitization<br>of film images,<br>acceptance of digital<br>images directly from<br>different medical image<br>modalities, and quality<br>control review and<br>revision of studies. | Cemax Icon provides<br>PACS, computed<br>radiography and<br>teleradiology software.<br>The software is<br>scalable and addresses<br>all aspects of medical<br>image acquisition,<br>viewing, storage and<br>printing. | |
| Graphical User<br>Interface | Yes | Yes | Yes | Yes | |
| Platform | PC | PC | PC | Workstation | |
| Operating System | Windows NT,<br>Windows 2000 | Windows NT | Windows NT | UNIX | |
| Display Resolution | Up to 2048x2560 | 1024x768 | Up to 2048x2560 | Up to 2048x2560 | |
| | | | | | |
| Feature | | | | | |
| Product | AETmed Image<br>Processing software<br>(This submission) | VIEW NTTM | Radworks Medical<br>Imaging Software<br>with Quality Control<br>Module | Accurad Image<br>Management System,<br>AutoRad Regustr | |
| Gray scale resolution | From 8 bits, 256 levels<br>to 24 bits true color | 8 bits, 256 levels | From 8 bits, 256 levels<br>to 24 bits true color | From 8 bits, 256 levels<br>to 24 bits true color | |
| Multi-monitor<br>support | Yes | Yes | Yes | Yes | |
| Patient Demographics | Yes | Yes | Yes | Yes | |
| Networking | TCP/IP | TCP/IP | TCP/IP | TCP/IP | |
| Image<br>Communication | DICOM Compliant | DICOM Compliant | DICOM Compliant | DICOM Compliant | |
| DICOM Compliant | Yes | Yes | Yes | Yes | |
| Image Compression | JPEG loss-less | JPEG loss-less, JPEG<br>lossy | JPEG loss-less, JPEG<br>lossy | JPEG loss-less, JPEG<br>lossy | |
| Video signals<br>grabbing | Yes | Yes | Yes | Unknown | |
| Analogic Video Input<br>format | 525, 625, 1023, 1049,<br>1249; interlaced or<br>progressive | 525, 625, 1023, 1049,<br>1249; interlaced or<br>progressive | 525, 625; interlaced or<br>progressive | N/A | |
| Analogic Video Input<br>rate | <= 30 fps | <= 30 fps | < 30 fps | N/A | |
| Image Archiving<br>(Hard Disk) | Yes | Yes | Yes | Yes | |
| Image Archiving<br>(Removable media) | CD-R, MOD, DVD,<br>DLT, other DICOM<br>Entities | CD-R, other DICOM<br>Entities | CD-R, MOD, DVD,<br>DLT, other DICOM<br>Entities | CD-R, MOD, DVD,<br>DLT, other DICOM<br>Entities | |
| Image Review | Still images, cine-<br>loops, Window, level,<br>zoom, magnifying lens,<br>Configurable layout | Still images, cine-<br>loops, Window, level,<br>zoom, magnifying lens | Still images, cine-<br>loops, Window, level,<br>zoom, magnifying lens,<br>Configurable layout | Still images, cine-<br>loops, Window, level,<br>zoom, magnifying lens,<br>Configurable layout | |
| Image Processing | Annotations, Distances,<br>Angles, Pixel Values,<br>Pixel Distribution,<br>Grey level statistics,<br>Quantitative Coronary<br>Analysis, Left<br>Ventricle Analysis | Annotations, Distances,<br>Angles, Pixel Values,<br>Pixel Distribution,<br>Grey level statistics,<br>Quantitative Coronary<br>Analysis, Left<br>Ventricle Analysis | Annotations, Distances,<br>Angles, Pixel Values,<br>Pixel Distribution,<br>Grey level statistics | Annotations, Distances,<br>Angles, Pixel Values,<br>Pixel Distribution,<br>Grey level statistics | |
| 3D Image Processing | MPR, MIP, mip,<br>Volume rendering | No | MPR, MIP, mip,<br>Volume rendering | Unknown | |
| Quality Control | Yes | Unknown | Yes | Yes | |
| Workflow<br>management | Yes | Unknown | Yes | Yes | |
| Image Database | Yes | Yes | Yes | Yes | |

## Table 1 – Substantial Equivalence Comparison Chart

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2001

AETmed S.P.A. % Ms. Colleen Hittle Partner The Anson Group, LLC 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K012093

Trade/Device Name: AETmed Image Processing Software PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications Sys Regulatory Class: II Product Code: 90 LLZ Dated: July 3, 2001 Received: July 5, 2001

Dear Ms. Hittle:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreated of the enactment date of the Medical Device Amendments, or to commerce pror to thay 20, 1978, as tax can and with the provisions of the Federal Food, Drug, do noos mat hat ( 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 r ou may, diererors, mainer and act include requirements for annual registration, listing of general controls proficiting 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 your dovies is classified not one of . Existing major regulations affecting your device can be it may be subject to additions, 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 I reaso be devised that I Dr resean that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or car) I vith all the Act's requirements, including, but not limited to: registration and listing oonly - nattan and 1100 included to the Part 801); good manufacturing practice requirements as set (21 OF ICP art 807), accommy (21 CFR Part 820); and if applicable, the electronic rently and quinny by of the 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 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:

| 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" (21 CFR Part 807.97). 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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# Indications for Use Statement

Applicant: AETmed, S.p.A.

510(k) Number (if known): __ KO12093

Device Name: AETmed Medical image processing software

Indications For Use:

The AETmed Medical image processing Software is a software device intended to be used by THE ALT HEC Medical medically of the proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical capturing, retrioving, nowlig, provised graphy, and general radiological studies.

### (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over The Counter Prescription Use

(Per 21 CFR. 801.109)

(Optional Format 1-2-96)

Nancy C. Beagdon

(Division Sign-Off
Division of Reproductive, Abdominel,
and Radiological Devices
510(k) Number K012093