(42 days)
Not Found
No
The document describes a standard PACS system for image management and processing, with no mention of AI or ML capabilities. The focus is on image storage, communication, and display for physician interpretation.
No.
The device is a PACS system for managing and displaying medical images, which aids in diagnosis rather than providing direct therapy.
No
The device is described as a PACS system that manages and facilitates access to medical images, making the diagnosing process easier, but it does not perform the diagnosis itself. A physician interprets the images.
Yes
The device is described as a "software based device" and a "completely DICOM compliant PACS system, integrating the client and server applications". While it interacts with hardware (imaging modalities, monitors), the core device being cleared is the software system for image management, processing, and display. The description focuses on the software's functionality and integration within a network, not on any specific hardware components being part of the cleared device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- IQPACS Functionality: The description of IQPACS clearly states its purpose is to receive, store, communicate, process, and display digital images and data from various imaging modalities (CT, MR, ultrasound, etc.). It facilitates the management and access of these images for diagnostic purposes.
- Lack of Specimen Handling: There is no mention of IQPACS interacting with or analyzing biological specimens. Its focus is on the management and display of medical images.
Therefore, IQPACS falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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: +4 (021) 243-0590 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
1
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".
2
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.
3
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 (800) 638-2041 or (301) 443-6597 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
4
(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 ................................................................................................................................................................