(46 days)
Not Found
No
The document describes a standard PACS system for image archival and communication, with no mention of AI, ML, or related technologies in the intended use, device description, or other sections.
No.
The device is a software-based Picture Archival and Communication System (PACS) for managing and displaying medical images, not for diagnosis, treatment, or therapy.
No
The device is a Picture Archival and Communication System (PACS) that receives, stores, processes, and displays digital images. While it facilitates image viewing at diagnostic workstations, its function is data management and display, not the direct diagnosis of medical conditions.
Yes
The device is explicitly described as "software based" and its function is centered around receiving, storing, communicating, processing, and displaying digital images and data. While it interacts with hardware (scanners, monitors, storage devices), the core medical device functionality described is software-driven image management and viewing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device, rChive™ PACS, is a Picture Archival and Communication System. Its function is to receive, store, communicate, process, and display digital images from various medical imaging modalities (CT, MR, ultrasound, etc.).
- The intended use and device description clearly focus on managing and displaying medical images, not analyzing biological specimens.
Therefore, rChive™ PACS falls under the category of medical imaging software and is not an IVD.
N/A
Intended Use / Indications for Use
rChive™ PACS 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
LLZ
Device Description
rChive™ PACS is a Picture Archival and Communication System (PACS), which facilitates image viewing at diagnostic, reporting, consultation and remote computer workstations, as well as archiving of pictures on magnetic or optical media using short or long-term storage devices. rChive™ PACS allows communication using local or wide-area networks, public communications services, systems that include modality interfaces and gateways to healthcare facility and departmental information systems.
Mentions image processing
system, image processing, radiological
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
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
October 20, 2006
Submitter's Information: 21 CFR 807.92(a)(1)
Dr. Madhu Nambiar, CEO Sobha Renaissance Information Technology Private Limited SRIT House, # 113 / 1B ITPL Main Road Kundalahalli, Bangalore 560037 Karnataka, India
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | rChive™ PACS |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Classification Name: | system, image processing, radiological |
| Product code: | LLZ |
| Device Classification: | 892.2050 |
Predicate Device: 21 CFR 807. 92(a)(3)
| rChive™ PACS is substantially equivalent to: | |
|---|---|
| Manufacturer: | NEOBIT CO., LTD |
| Device Name: | MEDIPACS |
| 510(k) Number: | K040486 |
| Decision Date: | 03/15/2006 |
| Decision: | Substantially Equivalent |
| Product Code: | LLZ |
| Device Classification Name: | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Regulation Number: | Class II - 892.2050 |
Device Description: 21 CFR 807 92(a)(4)
rChive™ PACS is a Picture Archival and Communication System (PACS), which facilitates image viewing at diagnostic, reporting, consultation and remote computer workstations, as well as archiving of pictures on magnetic or optical media using short or long-term storage devices. rChive™ PACS allows communication using local or wide-area networks, public communications services, systems that include modality interfaces and gateways to healthcare facility and departmental information systems.
Indications for Use: 21 CFR 807 92(a)(5)
rChive™ PACS is a software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F
DEC 1 2 2005
1
510(k) Summary of Safety and Effectiveness
Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.).
lmages 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.
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 rChive™ PACS contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The two systems, MEDIPACS ™ (predicate) and the rChive ™ PACS devices are both complete PACS systems indicated for medical image and data distribution. Both systems have been developed to replace traditional film handling in radiology. The 2 devices are substantially equivalent in the areas of design architecture, general function, application, and intended use. Any differences between the two devices will not affect safety or efficacy.
rChive™ PACS 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
Image /page/2/Picture/0 description: The image shows a circular logo with the text "DEPARTMENT OF HEALTH & HUMAN..." arranged around the circumference. Inside the circle is a stylized graphic consisting of three curved lines that resemble a bird in flight or abstract waves. The logo is black and white and appears to be a seal or emblem.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Sobha Renaissance Information Technology Private Limited % Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210
DEC 1 2 2006
Re: K063253
Trade/Device Name: rChive™ PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 22, 2006 Received: October 27, 2006
Dear Mr. Alletto:
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 (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is a large, bold "FDA". The word "Centennial" is written in a cursive font below the FDA letters. Three stars are centered below the word "Centennial". The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.
Protecting and Promoting Public Health
3
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.
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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/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
Page 2 -
4
510(k) Number: Kolo 32 53
Device Name:
Indications for Use:
rChive™ PACS 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 gatevanps, etc. L
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 。 1 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 acccpted by FDA.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | AND/OR | Over-The-Counter Use | |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K063253 |
|---|---|
| --------------- | --------- |