DICOMNET

K961451 · Lockheed Martin Communications Systems · IZI · Jul 3, 1996 · Radiology

Device Facts

• Record ID: K961451
• Device Name: DICOMNET
• Applicant: Lockheed Martin Communications Systems
• Product Code: IZI · Radiology
• Decision Date: Jul 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

DicomNet is intended to be used for storing and displaying digital images acquired and stored by digital imaging systems on DICOM interchange media. DicomNet reviews images directly from the DICOM storage media (CD-Recordable disks) and can store the images in an archive manager for review on any of the network review stations. The system stores unaltered/uncompressed computer digital data.

Device Story

DicomNet; digital image storage/display system. Inputs: DICOM images from CD-Recordable/MO disks. Components: Cardiac Review Station (Power PC/Pentium CPU for playback/annotation); Archive Manager (workstation file server using Metior or LSC HFM); DLT Drive (high-density tape archive); Automatic Tape Library (robotic storage); RAID (on-line staging); ATM switch (network routing). Operation: Reads DICOM data from interchange media; archives data; enables network-wide review. Used in clinical settings by healthcare providers to manage/view patient image databases. Benefits: Centralized archival/retrieval of digital imaging data.

Clinical Evidence

Bench testing only. Validation of calculation models performed using phantoms; Failure Mode and Effects Analysis (FMEA) conducted to identify controls; adherence to UL standards.

Technological Characteristics

System components: Power PC/Pentium-based workstations, DLT tape drives, robotic tape library, RAID storage, ATM network switch. Software: Hierarchical File Manager (Metior HFM or LSC HFM). Connectivity: Networked DICOM-compliant system. Standards: DICOM interchange media.

Indications for Use

Indicated for storage and display of digital images acquired by digital imaging systems for clinical review.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• GEMnet (K943355)

Submission Summary (Full Text)

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K961451

# 510(k) Summary

## Identification of the Product

**JUL - 3 1996**

- **Trade Name:** DicomNet
- **Common Name:** Unknown
- **Classification Name:** Angiographic X-Ray System (accessory)

### Manufacturer:

Lockheed Martin
Communication Systems
1 Federal Street (A&E 1C)
Camden, NJ 08103
[phone]
[phone] (fax)

### Contact Person:

Vincent J. Napoleon

### Date Prepared:

01 April 1996

### Indications for Use:

DicomNet is intended to be used for storing and displaying digital images acquired and stored by digital imaging systems on DICOM interchange media. DicomNet reviews images directly from the DICOM storage media (CD-Recordable disks) and can store the images in an archive manager for review on any of the network review stations. The system stores unaltered/uncompressed computer digital data.

### Device Descriptions:

DicomNet is composed of the following:

- **Cardiac Review Station:** A Power PC or Pentium based cpu review station capable of playback and annotation of images recalled from archival storage or read directly from MO disk.

- **Archive Manager:** A workstation file server that provides management functions to the patient image database. The archive manager uses either the Metior HFM (Hierarchical File Manager) from Automated Network Technologies or the LSC HFM from Large Storage Configurations Inc.

- **DLT Drive:** A high density, high speed, random access 1/2 inch tape archive providing real-time storage and retrieval of digital images.

- **Automatic Tape Library:** A robotic tape library incorporating at least 1 but as many as 4 DLT drives that can be configured to store tens of thousands of patients on-line.

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RAID: Redundant Array of Inexpensive Disks: Provides on-line storage of tens of patients, used for staging images from and to robotic tape library.

ATM Switch: (Asynchronous Transmission Mode) switch is a high performance network router that allows multimegabit per second transmission (point to point) from any peripheral in the network.

## Marketing History

In the opinion of Lockheed Martin, DicomNet is comparable and substantially equivalent to the following device:

| Model | Manufacturer |
| --- | --- |
| GEMnet (K943355) | GE Medical Systems |

The essential difference between DicomNet and GEMnet is DicomNet reads DICOM images from MO disks for network and archival while GEMnet formats directly from the digital acquisition system.

## Potential Adverse Effects on Health

The potential concerns are controlled by:
- Failure Mode and Effects Analysis (FMEA) to identify required controls
- Validation of the calculation models by phantoms
- Adherence to industry standards (UL)

## Conclusions

The principles of operation of DicomNet are almost identical to the currently marketed product GEMnet. this system poses no added risk of safety.