Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard PACS system for viewing, storing, and managing medical images. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image analysis, diagnosis support, or workflow optimization beyond basic PACS functionality.

Therapeutic

No.
CLARISO PACS is a software system for viewing, storing, and managing DICOM images and related patient information; it does not list any therapeutic claims or functions.

Diagnostic

No

Explanation: CLARISO PACS is a software system intended for viewing, organizing, and storing DICOM images and related information. It is described as a "viewing tool" and used for purposes like hard copy replacement, remote access, electronic image integration, and workflow management. The text explicitly states it's "not intended for the acquisition of mammographic image data" and is a service for "PACS functionality." While it facilitates access to images that may be used for diagnosis, the device itself does not perform any diagnostic analysis or generate diagnostic conclusions. It supports the diagnostic process by providing access to data for qualified personnel.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "CLARISO PACS™ is a software system" and describes its functions as receiving, organizing, storing, and making available DICOM images and related information via network and user interfaces. It focuses on software functionalities like viewing, workflow management, and integration with other systems, without mentioning any proprietary hardware components.

IVD (In Vitro Diagnostic)

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 CLARISO PACS is a software teleradiology system used to receive, organize, store, and make available medical images and related information. It is used by medical personnel for viewing and managing radiological image data. This aligns with the definition of a medical image management and viewing system, not an IVD.
Device Description: The description reinforces that it's a viewing tool for studies within a medical facility, a hard copy replacement, a remote access tool, an electronic image integration platform, and a radiology workflow management tool. None of these functions involve testing samples taken from the human body to provide diagnostic information.
Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health status, diagnose diseases, or monitor treatment. CLARISO PACS does not perform any such tests. Its input is medical imaging data, not biological samples.

In summary, CLARISO PACS is a medical device, specifically a Picture Archiving and Communication System (PACS), used for managing and viewing medical images. It does not fit the definition or function of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

CLARISO PACS is a software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. CLARISO PACS is used by hospitals, imaging centers, radiologist reading practices.

CLARISO PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.

Product codes

LLZ

Device Description

CLARISO PACS™ is a software system to be used to view DICOM compliant studies, which are stored within the CLARISO PACS™ . CLARISO PACS™ is intended for professional use only as a viewing tool for studies within a medical facility. CLARISO PACS™ is a 'Continuous Use' device. This device is also compliant with HIPAA regulations regarding patient privacy (such as restricting access to particular studies, logging access to data.). Since there is no direct patient interaction with the device, there is no possibility that CLARISO PACS™ might lead to a fatal fault or injury to the patient. The only two most likely causes of a fault would be the change of the computing environment of the Client system, or a mislabeling of the DICOM studies used by the Viewer. In the best-case scenario, CLARISO PACS™ would be able to operate safely in spite of such faults. The strategy of CLARISO PACS™ in fault handling is to keep its normal operation as much as it can. The CLARISO PACS™ is intended to work as a standalone service that provides common PACS functionality. The main objective of CLARISO PACS™ is to be a service that can be embedded in other applications that require PACS functionality.

CLARISO PACSTM has four main uses:

Hard copy replacement: PACS replaces hard-copy based means of managing . medical images, such as film archives.
Remote access: It expands on the possibilities of conventional systems by providing . capabilities of off-site viewing and reporting (distance education, tele-diagnosis). It enables practitioners in different physical locations to access the same information simultaneously for teleradiology.
Electronic image integration platform: PACS provides the electronic platform for radiology images interfacing with other medical automation systems such as Hospital Information System (HIS), Electronic Medical Record (EMR), Practice Management Software, and Radiology Information System (RIS).
Radiology Workflow Management: PACS is used by radiology personnel to manage the workflow of patient exams.

Mentions image processing

System, Image Processing, Radiological

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT, MR, US, PET

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified medical personnel only who are qualified to create and diagnose radiological image data.
hospitals, imaging centers, radiologist reading practices.

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

The complete CLARISO PACS™ system configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification & Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the CLARISO PACS™ software in each operational mode and followed the process documented in the Validation Test Plan.

Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. If the device is installed by CLARISO Inc., integration and installations verification tests are conducted against acceptance criteria prior to release to the client.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Key Metrics

Not Found

Predicate Device(s)

K061421

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

K132799
Page 1 of 5

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

Date Prepared:

October 27, 2013

Submitter's Information: 21 CFR 807.92(a)(1)

Mr. Cody D. Ebberson, CEO Clariso, Inc. 55 Page Street #824 San Francisco, CA 94102 Email: cody@clariso.com

NOV 07 2013

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name:	CLARISO PACSTM
Common Name:	Picture, archive and communications system
Classification Name:	System, Image Processing, Radiological
Product Code:	LLZ

Predicate Device: 21 CFR 807. 92(a)(3)

Device Classification Name	system, image processing, radiological
510(k) Number	K061421
Device Name	ERAD PACS
Original Applicant	ERAD, INC.
16303 Panoramic Way
San Leandro, CA 94578
Regulation Number	892.2050
Classification Product Code	LLZ
Decision Date	07/25/2006
Decision	substantially equivalent (SE)
Classification Advisory Committee	Radiology
Review Advisory Committee	Radiology
summary	summary
Type	Traditional
Reviewed by Third Party	No
Expedited Review	No
Combination Product	No

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

CLARISO PACS™ is a software system to be used to view DICOM compliant studies, which are stored within the CLARISO PACS™ . CLARISO PACS™ is intended for professional use only as a viewing tool for studies within a medical facility. CLARISO PACS™ is a 'Continuous Use' device. This device is also compliant with HIPAA regulations regarding patient privacy (such as restricting access to particular studies, logging access to data.). Since there is no direct patient interaction with the device, there is no possibility that CLARISO PACS™ might lead to a fatal fault or injury to the patient. The only two most likely causes of a fault would be the change of the computing environment of the Client system, or a mislabeling of the DICOM studies used by the Viewer. In the best-case scenario, CLARISO PACS™ would be able to operate safely in spite of such faults. The strategy of CLARISO PACS™ in fault handling is to keep its normal operation as much as it can. The CLARISO PACS™ is

1

intended to work as a standalone service that provides common PACS functionality. The main objective of CLARISO PACS™ is to be a service that can be embedded in other applications that require PACS functionality.

CLARISO PACS™ has four main uses:

Hard copy replacement: PACS replaces hard-copy based means of managing . medical images, such as film archives.
Remote access: It expands on the possibilities of conventional systems by providing . capabilities of off-site viewing and reporting (distance education, tele-diagnosis). It enables practitioners in different physical locations to access the same information simultaneously for teleradiology.
. Electronic image integration platform: PACS provides the electronic platform for radiology images interfacing with other medical automation systems such as Hospital Information System (HIS), Electronic Medical Record (EMR), Practice Management Software, and Radiology Information System (RIS).
. Radiology Workflow Management: PACS is used by radiology personnel to manage the workflow of patient exams.

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

CLARISO PACS™ is a software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. CLARISO PACS™ is used by hospitals, imaging centers, radiologist reading practices. CLARISO PACS™ is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.

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

CLARISO PACS™ is a software application that handles and manipulates digital medical images. 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. In general, a PACS (Picture Archiving and Communication System) is a medical imaging technology which provides storage of, and convenient access to, images from multiple modalities. Electronic images and reports are transmitted digitally via PACS; this eliminates the need to manually file, retrieve, or transport film jackets. The universal format for PACS image storage and transfer is DICOM 3.x (Digital Imaging and Communications in Medicine). Non-image data, such as scanned documents, may be incorporated using consumer industry standard formats like PDF (Portable Document Format), once encapsulated in DICOM. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. 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, and intended use. The predicate device and the new device are compared below:

| ltem | Functionality (ERAD PACS) and or Efficacy |------|------------------ | | Web Browser Software Windows application features. Microsoft
Internet Explorer &
Mozilla Firefox for features
except the DICOM Chrome web browser instead of
using a custom Windows
application. See reference #1
below. |
| 2 | Intended use editing and storing
radiographs and
related patients images | Same | 3 | Intended user | 4 | Network | 5 | Monitor (Above 1280x900) | 6 | User interaction/input | 7 | Import / export images | 8 | Acquisition devices | 9 | Image organization study instance UID | 10 | Image search available | 11 | Image storage | 12 | Database software | 13 | Greyscale Image
Rendering | Yes | 14 | RGB Image Rendering | 15 | Localizer Lines | 16 | Localizer Point | 17 | Orientation Markers | 18 | Distance Markers | 19 | Study Data Overlays | 20 | Stack Navigation | 21 | Window Level | 22 | Zoom in on images | 23 | Panning | 24 | Horizontal/Vertical Flip | 25 | Clockwise/Counterclockwis
e rotate | Yes | 26 | Invert image | 27 | Text Annotation | 28 | Area measurement
annotation | Yes | 29 | Angle measurement
annotation | Yes | 30 | Cobb Angle Measurement
Annotation | Yes | 31 | Image annotation | 32 | Image operations | 33 | Security | 34 | DICOM 3.0 conformance | 35 | Worklist | 36 | Thumbnail viewing thumbnails available instead of just one size. See
Reference #2 below. | 37 | Login | 38 | Audit audit trail at any time in real
time. See Reference #3 below. | Predicate device
| CLARISO PACS™ | If different, Impact on Safety
|
---------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Custom Microsoft
| Google Chrome for all
Viewer | Provides access in the Google
| Acquiring, viewing,
| No difference |
| Radiologist | Radiologist | No difference |
| 10/100/100 Ethernet | Same | No difference |
| Above 19inch monitor
| Same, Using 1280x1024 | No difference |
| Mouse and keyboard | Same | No difference |
| Yes | Yes | No difference |
| CT, MR, US, PET | Same | No difference |
| Yes. Patient ID, Name.
| Same | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| MySQL | MySQL | No difference |
| Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | No difference |
| Yes | No difference |
| Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Yes | No difference |
| Yes | Different sizes of
| Provides 3 sizes of thumbnails
|
| Yes | Yes | No difference |
| Yes | Yes | Provides the ability to see the
|

2

.

3

| Ref #
related to

differences	Functionality or Item	Impact on Safety and or Efficacy
1	Software/Hardware
Requirements	The new device CLARISO PACS™ requires Google Chrome Browser to view
image data. The predicate device, eRAD PACS installs a custom Windows
application to view image data. The new device uses the Google Chrome web
browser. Increasingly, practitioners prefer to use Google Chrome instead of
installing a Windows Application because web browsers are more convenient and
users already know how to use them. The function of the hardware and software
are the same and the use of a Google Chrome web browser in the subject device
does not raise any new potential safety risks. The subject device is equivalent in
performance to existing legally marketed devices and was based upon the
software developed for the predicate eRAD PACS. Therefore, it is our
determination that there is "No impact on safety or efficacy"
36	Thumbnail viewing	There are slight differences in Thumbnail Viewing, The new device CLARISO
PACS™ supports three sizes of thumbnails on preview, small, medium and large.
The old device only supports medium sized thumbnails. This difference
differences does not raise any new potential safety risks and gives the user
additional flexibility. The subject device is equivalent in performance to existing
legally marketed devices and was based upon the software developed for the
predicate eRAD PACS. Therefore, it is our determination that there is "No impact
on safety or efficacy"
38	Audit	The new device adds a tool to view access logs in real time. The predicate device
eRAD PACS doesn't have this kind of tool. In ERAD PACS audit trails need to be
generated offline with a lag. Since the subject device has real time log access it
gives the user added flexibility and does not raise any new potential safety risks.
The subject device is equivalent in performance to existing legally marketed
devices and was based upon the software developed for the predicate eRAD
PACS. Therefore, it is our determination that there is "No impact on safety or
efficacy"

Nonclinical Testing:

The complete CLARISO PACS™ system configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification & Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the CLARISO PACS™ software in each operational mode and followed the process documented in the Validation Test Plan.

4

KB2799
Page 5 of 5

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. If the device is installed by CLARISO Inc., integration and installations verification tests are conducted against acceptance criteria prior to release to the client.

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

The 510(k) Pre-Market Notification for CLARISO PACS™ contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The subject and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The modification to the subject device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Therefore, CLARISO PACS™ is substantially equivalent to the predicate devices.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES, USA

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO06-G609 Silver Spring, MD 20993-0002

November 7, 2013

Clariso, Inc. % Mr. Carl Alletto Consultant OTech, Inc. 111 Melanic Drive AUBREY TX 76227

Re: K132799

Trade/Device Name: CLARISO PACS" Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 1.LZ Dated: October 28, 2013 Received: November 1, 2013

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 10 devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmativ 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. Ilisting 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.

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 (reporting of medical device-related adverse events) (21 CFR 803): 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.

6

Page 2-Mr. Alletto

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

7

Indications for Use

510(k) Number (if known): K132799

Device Name: CLARISO PACS

Indications for Use:

CLARISO PACS is a software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. CLARISO PACS is used by hospitals, imaging centers, radiologist reading practices.

CLARISO PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.

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 In Vitro Diagnostics and Radiological Health (OIR)

ming ma
---------	--

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K132799

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