CENTRICITY PACS PLUS

K023557 · GE Medical Systems · LLZ · Nov 7, 2002 · Radiology

Device Facts

• Record ID: K023557
• Device Name: CENTRICITY PACS PLUS
• Applicant: GE Medical Systems
• Product Code: LLZ · Radiology
• Decision Date: Nov 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The Centricity PACS Plus system is used to transmit, store and display images throughout a clinical environment. The Centricity PACS Plus is an image display software application that is intended for use by qualified physicians and other personnel for reading, diagnostic review, and analysis of digital images acquired from imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices. As a part of the PACS Plus system the Centricity RA1000 is used to view digital images that are obtained from a GE Centricity PACS System, or another DICOM device.

Device Story

Centricity PACS Plus is a software application for transmission, storage, and display of multi-modality medical images. It functions as a diagnostic review workstation for physicians and clinical staff. Inputs include digital images from CT, MR, CR, DX, MG, US, NM, PET, or other DICOM-compliant imaging devices. The system enables image selection, review, processing, filming, and media interchange to support radiology department workflows. It is used in clinical environments to facilitate diagnostic decision-making by providing high-quality image visualization. The device integrates into existing PACS infrastructure, allowing clinicians to view images obtained from GE Centricity PACS or other DICOM sources.

Clinical Evidence

Bench testing only. The manufacturer utilized a software development and validation process, including a software verification plan and a risk management plan, to ensure safety and effectiveness. No clinical study data was required or provided.

Technological Characteristics

Software-based image display application. Operates on standard workstation hardware. Supports DICOM standard for image acquisition and interoperability. Features include image selection, review, processing, and media interchange. No specific hardware materials or energy sources defined beyond standard computing equipment.

Indications for Use

Indicated for qualified physicians and clinical personnel to perform reading, diagnostic review, and analysis of digital medical images (CT, MR, CR, DX, MG, US, NM, PET) in clinical environments.

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

• Platinum Reading and Review Workstation (K981217)
• Siemens SieNET (K920319)

Submission Summary (Full Text)

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7 2002 NOV

GE Medical Systems Information Technologies

# 1023557 Centricity PACS Plus 510 (k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87 (h)

- 1. Identification of submitter: Scott R. Evans Regulatory Affairs Specialist Telephone: [phone] Fax: [phone]
Date Prepared: September 26th, 2002

#### 2. Identification of Product:

| Device name | Centricity PACS Plus |
|---------------------|----------------------------------|
| Classification name | PACS per 21CFR Section 892.2050 |
| Manufacturer/ | General Electric Medical Systems |
| Distributor | 800E. Business Center Drive |
| | Mount Prospect, IL 60056 |
| | USA |

#### 3. Marketed Devices

Centricity PACS Plus is substantially equivalent to the devices listed below:

| Model: | Platinum Reading and Review Workstation |
|---------------|-----------------------------------------|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K981217 |

| Model: | Siemens SieNET |
|---------------|----------------------------------|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K920319 |

### 4. Device Description :

See Attachment #2

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### 5. Indications for Use

The Centricity PACS Plus system is used to transmit, store and display images throughout a clinical environment. The Centricity PACS Plus is an image display software application that is intended for use by qualified physicians and other personnel for reading, diagnostic review, and analysis of digital images acquired from imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices. As a part of the PACS Plus system the Centricity RA1000 is used to view digital images that are obtained from a GE Centricity PACS System, or another DICOM device.

#### 6. Comparison with Predicate Device

Centricity PACS Plus is substantially equivalent to the devices listed below:

| Model: | Platinum Reading and Review Workstation | |
|---------------|-----------------------------------------|--|
| Manufacturer: | General Electric Medical Systems | |
| 510 (k): | K981217 | |
| Model: | Siemens SieNET | |
| Manufacturer: | General Electric Medical Systems | |
| 510 (k): | K920319 | |

These workstations allow easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.

#### 7. Conclusions

Centricity PACS Plus brings additional features in order to integrate seamlessly into the Radiology Department Workflow.

The entire potential new hazards has been studied by a Risk Management Plan:

- . Risk Management Summary
- A software development and validation process
- A software verification plan .

Centricity PACS Plus provides images comparable to the predicate devices.

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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized depiction of an eagle's head and neck, composed of three parallel, curved lines. The eagle faces to the right. The words "DEPARTMENT OF TRANSPORTATION" are arranged in a circular fashion around the eagle, with the text oriented to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

General Electric Medical Systems % Mr. Heinz Joerg Steneberg Division Manager Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

### · Re: K023557

Trade/Device Name: Centricity PACS Plus Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: 90 LLZ

Dated: October 21, 2002 Received: October 23, 2002

Dear Mr. Steneberg:

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 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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# STATEMENT OF INTENDED USE

K023557 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device name: Centricity PACS Plus

#### Indication For Use:

The Centricity PACS Plus system is used to transmit, store and display images throughout a clinical environment. The Centricity PACS Plus is an image display software application that is intended for reading, diagnostic review, and analysis of digital images acquired from imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices. As a part of the PACS Plus system the Centricity RA1000 is used to view digital images that are obtained from a GE Centricity PACS System, or another DICOM device.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div></div> |
|---------------------------------------|-------------|
|---------------------------------------|-------------|

-OR-

| Over-The-Counter Use | <div></div> |
|----------------------|-------------|
|----------------------|-------------|

Nancy Corogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K023557 |
|---------------|---------|
|---------------|---------|