(116 days)
No
The document describes standard image acquisition and processing software for digital radiography, with no mention of AI, ML, or related concepts.
No.
The device is described as software that acquires and processes X-ray images for diagnostic review, not for direct therapeutic intervention.
No
This device captures and processes X-ray images, which are then presented to the user. It does not analyze these images or provide any diagnostic information. Its function is to replace film radiographic examinations with digital image capture.
No
The device description explicitly states it is a "Windows based software application" that acquires images from "commonly commercialized digital flat panels" and presents them on a "touch screen computer monitor." While the core functionality is software, it relies on and interacts with specific hardware components (digital flat panels, touch screen monitor) for its operation and intended use. The performance studies also mention testing "utilizing the cleared digital image capture device." This indicates it's not purely software but a system where the software is a key component interacting with hardware.
Based on the provided information, the Cuattro UnoMD is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The Cuattro UnoMD, on the other hand, is a software application that processes and displays radiographic images generated by an x-ray machine.
- The intended use clearly states it's for capturing digital images in place of conventional film radiographic examinations. This is an imaging device, not a diagnostic test performed on biological samples.
- The device description focuses on image acquisition, processing, and display. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the Cuattro UnoMD falls under the category of a medical imaging device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cuattro UnoMD, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations.
The device is intended to be available for retrofit on existing or planned x-ray machines with a cleared digital image capture device.
The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications.
Product codes
LLZ
Device Description
The Cuattro UnoMD software is a Windows based software application capable of acquiring x-ray images from commonly commercialized digital flat panels. The software can use traditional mouse and keyboard inputs as well as touch screen monitors as an alternative. The use of the software enables the user to use a separate traditional x-ray generator and capture x-ray images without film. The images are processed and then presented to the user on a touch screen computer monitor, within 12 seconds after the x-ray exposure. The software also has capabilities to send images to hospital medical PACS systems and digital media for archival.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and qualified personnel
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)
Bench testing has been performed on the device following Cuattro's design control processes, as well as the applicable FDA guidance documents, in particular the guidance on Content of Premarket Submissions for Software Contained in Medical Devices. The results of this bench testing have demonstrated that the device is substantially equivalent to the referenced predicate device. Note: Testing was performed utilizing the cleared digital image capture device, Samsung LTX240 (K090742).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
.
T
. •
MAR - 5 2010
5 510(k) Summary
Image /page/0/Picture/3 description: The image shows the word "cuattro" in lowercase letters with a stylized four-leaf clover above it. The clover is black and appears to be hand-drawn or stylized. The word "cuattro" is in a simple, sans-serif font, and the overall design is clean and minimalist.
510(k) summary
October 25, 2009
510(k) Owner
Cuattro, LLC 2946 Court Street Pekin, IL 61554 Phone: 309-349-8901 309-349-8902 Facsimile:
510(k) Submitter
Mark Skeels Cuattro, LLC 40 Bram Bay Road Hopatcong, NJ 07843 Phone: 973-294-4363 973-770-8486 Facsimile:
Device Trade Name: Cuattro UnoMD System, Image Processing, Radiological Common Name: Classification Name: Picture archiving and communications system (21 CFR 892.2050, Product Code LLZ)
Substantial equivalence is claimed to the following Legally Marketed Device:
| Manufacturer: | Del Medical Imaging |
|---|---|
| Device: | DEL-IMS |
| 510(k) number: | K063188 |
Page 13 of 539
1
Device Description
The Cuattro UnoMD software is a Windows based software application capable of acquiring x-ray images from commonly commercialized digital flat panels. The software can use traditional mouse and keyboard inputs as well as touch screen monitors as an alternative. The use of the software enables the user to use a separate traditional x-ray generator and capture x-ray images without film. The images are processed and then presented to the user on a touch screen computer monitor, within 12 seconds after the x-ray exposure. The software also has capabilities to send images to hospital medical PACS systems and digital media for archival.
. .
1
Intended Use
The Cuattro UnoMD, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations. The device is intended to be available for retrofit on existing or planned x-ray machines with a cleared digital image capture device. The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications.
Technological Characteristics
The technological characteristics are the same as the legally marketed predicate device, in that they provide a network connection via DICOM protocol to various devices from a radiographic system that utilizes a digital image capture device. The Cuattro UnoMD device is a software solution intended for use with already cleared digital image capture devices. The Cuattro UnoMD, as the predicate device, utilize software on a workstation computer with Ethernet capability, and provide DICOM 3.0 compliant connectivity.
Determination of Substantial Equivalence
The determination of substantial equivalence is based upon non-clinical performance data. Bench testing has been performed on the device following Cuattro's design control processes, as well as the applicable FDA guidance documents, in particular the guidance on Content of Premarket Submissions for Software Contained in Medical Devices. The results of this bench testing have demonstrated that the device is substantially equivalent to the referenced predicate device. Note: Testing was performed utilizing the cleared digital image capture device, Samsung LTX240 (K090742).
Conclusion
Based upon the analysis of the Intended Use, Technological Characteristics, and the results of the Bench Testing performed on the device, we have determined that the
2
Cuattro UnoMD is safe and effective, and substantially equivalent to the Predicate Device.
.. '
ﻟﻠﺴﻴﺮ ﺍﻟﻤﺴﺮ
.▲
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird with three stylized wing shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MAR - 5 2010
Cuattro LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology services LLC 1394 25" Street NW BUFFALO MN 55313
Re: K093480 Trade/Device Name: Cuattro UnoMD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 8, 2010 Received: February 16, 2010
Dear Mr. Job:
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, Jrug, 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 24, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA roay publish finther 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 af 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/default.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/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement ব
Indications for Use
510(k) Number (if known):
Device Name: Cuattro UnoMD
Indications for Use:
The Cuattro UnoMD, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations.
The device is intended to be available for retrofit on existing or planned x-ray . machines with a cleared digital image capture device.
The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications.
Prescription Use X (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 Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093480
Page _ of __
Page 12 of 539