IQPACS

K060263 · S.C. Info World S.R.L. · LLZ · Mar 15, 2006 · Radiology

Device Facts

• Record ID: K060263
• Device Name: IQPACS
• Applicant: S.C. Info World S.R.L.
• Product Code: LLZ · Radiology
• Decision Date: Mar 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

IQPACS™ is a software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. 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

IQPACS is a DICOM-compliant PACS software system for clinical/hospital networks; integrates client and server applications. Inputs: digital images/data from CT, MR, ultrasound, R/F units, CR/DR, and secondary capture devices. Function: captures, stores, communicates, processes, and displays radiological images. Operation: used by clinicians/radiologists in clinical settings to facilitate image management and diagnostic workflows. Output: displayed images for physician review. Clinical impact: provides quick access to images; assists in diagnostic process. Benefit: improved workflow efficiency and image accessibility for healthcare providers.

Clinical Evidence

Bench testing only. No clinical data provided. The submission includes hazard analysis and documentation of compliance with voluntary standards.

Technological Characteristics

Software-based PACS; DICOM compliant. No patient contact. Operates on networked computer hardware. Connectivity: networked client-server architecture. Software hazard level: minor. Does not control life-sustaining devices.

Indications for Use

Indicated for clinical environments requiring management, storage, communication, processing, and display of digital medical images (CT, MR, US, R/F, CR/DR) across networks. Contraindicated for primary interpretation of lossy compressed mammographic images or 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).

Predicate Devices

• MEDIPACS™ System (K040486)

Submission Summary (Full Text)

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# Kobo263 510(k) Summary of Safety and Effectiveness

MAR 1 5 2006

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: January 25, 2006 Submitter's Information: 21 CFR 807.92(a)(1) Mr. Daniel Nistor, CEO S.C. INFO WORLD S.R.L. Intrarea Glucozei nr. 37-39 Tronson 3, Parter, Sector 2 Bucuresti, Romania Phone: [phone] Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) IQPACS™ Trade Name: Picture Archiving Communications System Common Name: 892.2050 Device Classification: System, Image Processing Name: Predicate Device: 21 CFR 807. 92(a)(3) The IQPACS™ PACS system is substantially equivalent to the: Manufacturer: NEOBIT CO., LTD. MEDIPACS™ System Device: 510(k) Number: K040486 03/11/2004 Decision Date: Substantially Equivalent Decision: Product Code: LLZ Device Classification Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Class II - 892,2050 Requlation Number:

Device Description: 21 CFR 807 92(a)(4)

IQPACS is a completely DICOM compliant PACS system, integrating the client and server applications in a clinic/hospital in a PACS network, facilitating the medical images management, offering quick access to radiological images, and making the diagnosing process easier. The IQPACS system consists of a number of applications that can be integrated in a PACS network, considering the client's needs and the specific of every clinical institution.

Indications for Use: 21 CFR 807 92(a)(5)

IQPACS™ is a software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image

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### 510(k) Summary of Safety and Effectiveness

interpretation. 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.

#### Technological Characteristics: 21 CFR 807 92(a)(6)

The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

#### Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for IQPACS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

IQPACS™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor".

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird or other winged creature.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

S.C. INFO WORLD S. R. L. % Mr. Carl Alletto Official Correspondent OTech, Inc. 1600 Manchester Way CORINTH TX 76210

Re: K060263 Trade/Device Name: IQPACSTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 1, 2006 Received: February 1, 2006

Dear Mr. Alletto:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed four ever est 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 rear 20, 1978, and 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 do not require approval or a provisions of the Act. The general controls provisions of the Act do hose 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your Apple rary, it affer and 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 clectronic 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 11 you don't the Office of Compliance at one of the following numbers, 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 807.97). You may obtain other general information on your responsibilities under the Act iron 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/industry/support/index.html.

Sincerely yours.

Nancy C. Brigdon

Nanev 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 Form)

510(k) Number: K 060263

Device Name: IQPACSTM

Indications for Use:

IQPACS™ is a software based device that receives digital images and data from various IQI ACS - 13 a software oused canners, ultrasound systems, R/F Units, computed & direct sodiographic devices, secondary capture devices, scanners, imaging gateways, etc.).

Images and data can be captured, stored, communicated, processed and displayed within the rmages and or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be Lossy conforessed manning rapretation. 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) AND/OR Over-The-Counter Use __ Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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