(224 days)
Not Found
No
The summary describes a standard PACS system for viewing, storing, and managing medical images and records. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic image processing and integration with other healthcare systems.
No
The device is a software for viewing and manipulating medical images, and does not directly treat or diagnose any condition.
No
This device is software specifically for viewing, manipulating, processing, managing, storing, and communicating medical images and other healthcare records. It does not generate diagnostic information itself, but rather supports the workflow for human interpretation. The text also explicitly states that lossy compressed mammographic images must not be reviewed for primary image interpretation on this PACS, and mammographic images require an FDA cleared display for interpretation.
Yes
The device description explicitly states "NeoRad PACS is a software device" and details its function as a server application using web-based technology for viewing, manipulating, and managing medical images and records. While it interacts with hardware (imaging devices, computers, servers), the device itself, as described, is the software component.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that NeoRad PACS is a software device used for viewing and manipulating medical images and other healthcare related electronic records. It focuses on the management, storage, and communication of these records.
- Device Description: The description reinforces this by detailing its function as an Image Archive and Report Repository and its capabilities related to storing and retrieving DICOM objects and processing HL7 messages.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. NeoRad PACS does not perform any such analysis of biological specimens. Its function is centered around the handling of existing medical images and records.
While the software is used in a healthcare setting and is related to diagnosis (as it handles images used for diagnosis), its function is not the in vitro analysis of specimens, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
NeoRad PACS is a software device used for viewing and manipulating medical images and other healthcare related electronic records. Digital imaging units (including DR, CR, CT, MR, US, RF and 2D/3D mammography), other computed and direct radiographic devices, secondary capture devices, document and film scanners, imaging gateways, other imaging devices and healthcare related electronic records can be displayed, processed, managed, stored and communicated across computer networks using this software.
NeoRad PACS, can be integrated with a facility's existing Electronic Medical Records System (EMR), Hospital Information System (HIS), Practice Management System, Radiology Information System (RIS) and Dictation System. NeoRad PACS, may also be integrated with the facility's Teleradiology Provider systems. These integrations provide seamless operation and access for Providers and other caregivers to the entire spectrum of patient's radiology records from the Provider's orders, to images of the exam, to completion data all the way to the interpretations (results/reports).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the NeoRad PACS. Mammographic images may only be interpreted using an FDA cleared display that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by the FDA.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
NeoRad PACS uses web-based technology and a secure operating system. This means that virtually any computer at any location can use an Internet browser to access NeoRad PACS systems. Whether on-site or from another location, physicians can manage, edit, view and move diagnostic exams quickly and efficiently. As part of NeoRad PACS support, Everrtech Software performs the system maintenance within its scope. NeoRad PACS, has been designed to be expandable, with storage beginning at 2 TB and growing to 25 TB onboard or 256 TB expansion.
NeoRad PACS is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities:
· To store and retrieve various kinds of DICOM Objects such as:
-
Images from multiple modalities,
-
Grayscale Presentation States, which specifies the presentations of images as gray scaling, zoom, text and graphical annotations,
-
Key Objects, which specifies a particular selection of images for a specified reason and with an attached note,
· To process HL7 notification messages from the Order Filler, about Procedure Updates and Patient Information Updates,
NeoRad PACS is a server application. Its Web-based User Intended for system configuration and monitoring by system administrators.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital imaging units (including DR, CR, CT, MR, US, RF and 2D/3D mammography), other computed and direct radiographic devices, secondary capture devices, document and film scanners, imaging devices.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Providers and other caregivers in a facility with an existing Electronic Medical Records System (EMR), Hospital Information System (HIS), Practice Management System, Radiology Information System (RIS) and Dictation System. May also be used with Teleradiology Provider systems.
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)
The NeoRad PACS has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate output functions and actions performed by Evertech Software PVT LTD and followed the process documented in the Validation Test Plan. Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification activities and that the results demonstrated that the predetermined acceptance criteria were met.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Everrtech Software PVT LTD Josh Baker Consultant A306 Western Edge II Borivali East Mumbai. 400066 India
Re: K232641
April 10, 2024
Trade/Device Name: Neorad Pacs (Neorad Pacs) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: March 11, 2024 Received: March 11, 2024
Dear Josh Baker:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232641
Device Name NEORAD PACS (NEORAD PACS)
Indications for Use (Describe)
NeoRad PACS is a software device used for viewing and manipulating medical images and other healthcare related electronic records. Digital imaging units (including DR, CR, CT, MR, US, RF and 2D/3D mammography), other computed and direct radiographic devices, secondary capture devices, document and film scanners, imaging gateways, other imaging devices and healthcare related electronic records can be displayed, processed, managed, stored and communicated across computer networks using this software.
NeoRad PACS, can be integrated with a facility's existing Electronic Medical Records System (EMR), Hospital Information System (HIS), Practice Management System, Radiology Information System (RIS) and Dictation System. NeoRad PACS, may also be integrated with the facility's Teleradiology Provider systems. These integrations provide seamless operation and access for Providers and other caregivers to the entire spectrum of patient's radiology records from the Provider's orders, to images of the exam, to completion data all the way to the interpretations (results/reports).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the NeoRad PACS. Mammographic images may only be interpreted using an FDA cleared display that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by the FDA.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ☑Prescription Use (Part 21 CFR 801 Subpart D) ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) #: | K232641 |
|---|---|
| 510(k) Summary | |
| Prepared on: 2024-03-11 |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| ----------------- | --------------------- |
| Applicant Name | Everrtech Software PVT LTD |
|---|---|
| Applicant Address | A306 WESTERN EDGE II BORIVALI EAST MUMBAI 400066 India |
| Applicant Contact Telephone | 714-788-8152 |
| Applicant Contact | Mr. Josh Baker |
| Applicant Contact Email | josh@otconsulting.tech |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| ------------- | --------------------- |
| Device Trade Name | NEORAD PACS (NEORAD PACS) |
|---|---|
| Common Name | Medical image management and processing system |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 892.2050 |
| Product Code | LLZ |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K211863 | eVolve PACS | LLZ |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
NeoRad PACS uses web-based technology and a secure operating system. This means that virtually any computer at any location can
NeoRad PACS uses web-based technology and a secure operating system. This means that virtually any computer at any location can use an Internet browser to access NeoRad PACS systems. Whether on-site or from another location, physicians can manage, edit, view and move diagnostic exams quickly and efficiently. As part of NeoRad PACS support, Everrtech Software performs the system maintenance within its scope. NeoRad PACS, has been designed to be expandable, with storage beginning at 2 TB and growing to 25 TB onboard or 256 TB expansion.
NeoRad PACS is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities:
· To store and retrieve various kinds of DICOM Objects such as:
-
Images from multiple modalities,
-
Grayscale Presentation States, which specifies the presentations of images as gray scaling, zoom, text and graphical annotations,
-
Key Objects, which specifies a particular selection of images for a specified reason and with an attached note,
· To process HL7 notification messages from the Order Filler, about Procedure Updates and Patient Information Updates,
NeoRad PACS is a server application. Its Web-based User Intended for system configuration and monitoring by system administrators.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
NeoRad PACS is a software device used for viewing and manipulating medical images and other healthcare related electronic records. Digital imaging units (including DR, CR, CT, MR, US, RF and 2D/3D mammography), other computed and direct radiographic devices, secondary capture devices, document and film scanners, imaging devices and healthcare related electronic records can be displayed, processed, managed, stored and communicated across computer networks using this software.
4
NeoRad PACS, can be integrated with a facility's existing Electronic Medical Records System (EMR), Hospital Information System (HS), Practice Management System, Radiology Information System. NeoRad PACS, may also be integrated with the facility's Teleradiology Provider systems. These integration and access for Providers and other caregivers to the entire spectrum of patient's radiology records from the Provider's orders, to images of the exam, to completion data all the way to the interpretations (results/reports).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the NeoRad PACS. Mammographic images may only be interpreted using an FDA cleared display that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by the FDA.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The subject and predicate device indications for use are the same. The subject and predicate devices are both medical image management and processing systems, which are indical image management, review, and data distribution. Both systems have been developed to replace traditional film handling in radiology. The subject device are substantially equivalent in the areas of general function, and intended use. Any differences between the subject and predicate devices have no negative impact on the device safety or efficacy and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices.
Technological Comparison
21 CFR 807.92(a)(6)
Both the subject and predicate devices are software as a medical device. Any differences are due to improved technology or up-revision from the 3rd party applications between the new device and has no impact on safety or efficacy of the modified device and does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The NeoRad PACS has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate output functions and actions performed by Evertech Software PVT LTD and followed the process documented in the Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as reguired by the risk analysis, designated individuals performed all verification activities and that the results demonstrated that the predetermined acceptance criteria were met.
FDA Guidance on Cyber Security: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Document Issued on: October 2, 2014
FDA Guidance on Content of Premarket Submissions for Device Software Functions Document Issued on: June 14, 2023
Not Applicable
The non-clinical testing demonstrates that the subject device performs in accordance with its intended use, complies with the requirements specified in the FDA-recognized consensus standards, and meets the indicating that the subject device does not raise any new safety and/or effectiveness concerns and is substantially equivalent to the predicate.