JIVE X SOFTWARE

K053183 · Visus Technology Transfer GmbH · LLZ · Feb 16, 2006 · Radiology

Device Facts

• Record ID: K053183
• Device Name: JIVE X SOFTWARE
• Applicant: Visus Technology Transfer GmbH
• Product Code: LLZ · Radiology
• Decision Date: Feb 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

To be used with images from a variety of radiological modalities including CT, MRI, ultrasound, nuclear medicine, CR, DR, etc. to store and retrieve images and patient information. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Story

JiveX is a Picture Archiving and Communication System (PACS) designed for clinical environments. It ingests digital image data from various radiological modalities (CT, MRI, ultrasound, nuclear medicine, CR, DR). The system stores, manages, and retrieves these images and associated patient information for clinician review. It functions as a central repository for medical imaging data, enabling healthcare providers to access and display studies for diagnostic purposes. The device does not perform primary interpretation of lossy compressed mammograms or digitized film screen images; these require specific high-resolution display hardware. By facilitating efficient image access and management, JiveX supports clinical decision-making and workflow in radiology departments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PACS software for image storage, retrieval, and display. Supports standard radiological modalities (CT, MRI, US, NM, CR, DR). Requires 5 Mpixel resolution monitors for mammographic interpretation. Connectivity via standard medical imaging protocols.

Indications for Use

Indicated for storage and retrieval of radiological images and patient information from modalities including CT, MRI, ultrasound, nuclear medicine, CR, and DR. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images. Mammographic interpretation requires FDA-approved 5 Mpixel resolution monitors.

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).

Submission Summary (Full Text)

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## Public Health Service

FEB 1 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Visus Technology Transfer GmbH % Mr. Stephen Neushul President iCRco, Inc. 20406 Earl Street TORRENCE CA 90503

Re: K053183 Trade/Device Name: JiveX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 13, 2006 Received: January 17, 2006

Dear Mr. Neushul:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have teviewed your becaller 5 re(ts) prohestantially equivalent (for the indications for use stated in above and nave dolorinined the at reedicate devices marketed in interstate commerce prior to the cherosure to regary manteled probectical Device Amendments, or to devices that have been May 20, 1770, the onaominent and of the Federal Food, Drug, and Cosmetic Act (Act) that recials in accordation in accordation (PMA). You may, therefore, market the do not require approval of a premience approvisions of the Act. The general controls provisions of the Act device, subject to the general comeon prove, isting 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 (Premarket If your device is classined (500 acch additional controls. Existing major regulations affecting your Approval), it they 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 that I lease be advised that very in 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 r carrar statues and regulating, 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) (21 CFR Part 80 FR 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) This letter will anow you to begin mankemig your and equivalence of your device to a legally premarket notification. The PDA miding of subscantul vice 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 If you desire specific advice for your device on our labeling organisms, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation chilities, "Thisotanana on your responsibilities under the Act from the 180 807.97). You may obtain other general information your copyright 638-2041 or [phone] or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.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

510(k) Number (if known): K053183

Device Name: JiveX

Indications For Use:

To be used with images from a variety of radiological modalities including CT, MRI, ultrasound, nuclear medicine, CR, DR, etc. to store and retrieve images and patient information.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

David A. Seppon

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number .

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)