← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K062598 # IMT.LAB SOFTWARE (K062598) _Esaote Europe B.V. · LLZ · Oct 31, 2006 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K062598 ## Device Facts - **Applicant:** Esaote Europe B.V. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Oct 31, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Intended Use The IMT.LAB software is a Windows 2000/XP software application package to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote ultrasound systems. ## Device Story IMT.LAB is a Windows-based software application for PCs; processes carotid artery ultrasound video images (DICOM, BMP, JPEG) acquired from Esaote ultrasound systems. Device uses proprietary algorithms to automatically measure intima media thickness (IMT) from the far wall of the carotid artery. Results and images are stored on the PC hard disk for physician review. Used in clinical settings by physicians to aid in cardiovascular health assessment. Output provides quantitative IMT measurements, supporting clinical decision-making regarding patient cardiovascular risk. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing of the software's measurement capabilities compared to predicate devices. ## Technological Characteristics Windows 2000/XP software application; runs on standalone PC. Inputs: ultrasound video images (DICOM, JPEG, BMP). Processing: proprietary algorithms for automatic distance measurement of carotid artery intima media thickness. Connectivity: digital file transfer. Storage: local hard disk. No specific hardware materials or sterilization required as it is a software-only device. ## Regulatory 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. ## Special Controls *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). ## Predicate Devices - IMT.LAB ([K043360](/device/K043360.md)) - SonoMetric Health SonoCalc ([K030223](/device/K030223.md)) - Phillips QLAB ([K021966](/device/K021966.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Ko62598 510(k) Summary IMT.LAB Esaote Europe OCT 3 1 2006 # 510(k) Summary The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807.92(a). 807.92(a)(1) ## Submitter Information Carri Graham, Official Correspondent The Anson Group 11460 N. Meridian St., Ste. 150 Carmel, IN 46032 (317) 569-9500, extension 103 Phone: Facsimile: (317) 569-9520 Carri Graham Contact Person: Date: August 7, 2006 807.92(a)(2) | Trade Name: | IMT.LAB software | |-------------------------|---------------------------------------------| | Common Name: | Picture archiving and communications system | | Classification Name(s): | System, Image Processing, Radiological | | Classification Number: | 90 LLZ | 807.92(a)(3) ## Predicate Device(s) | Esaote Europe | IMT.LAB | K043360 | |-------------------|----------|---------| | SonoMetric Health | SonoCalc | K030223 | | Phillips | QLAB | K021966 | Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table. {1}------------------------------------------------ 510(k) Summary IMT.LAB Esaote Europe ### 807.92(a)(4) ## Device Description The IMT LAB software is a Windows 2000/XP software application package that runs on a stand-alone personal computer. Video images from the carotid artery made with a standard ultrasound system can be used as input for the IMT.LAB software package. These images can be transferred digitally by means of a DICOM, BMP, or JPEG files from the ultrasound system to the IMT.LAB software. IMT.LAB uses proprietary techniques and algorithms to measure the Intima Media Thickness (IMT) from the far wall of the carotid artery. This information is used in addition to other medical data by a physician to help assess the cardiovascular health of a patient. IMT.LAB can store the images and the measurement results on the hard disk for future reference. #### Intended Use(s) 807.92(a)(5) Esaote's IMT.LAB software is a Windows 2000/XP software application package. It is designed to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote ultrasound systems. {2}------------------------------------------------ #### Technological Characteristics 807.92(a)(6) ESAOTE believes that IMT.LAB is substantially equivalent to Esaote's IMT.LAB product (K043360), SonoMetric Health's SonoCalc product (K030223) and to Philips Medical Systems' QLAB product (K021966) | Characteristic | ESAOTE
IMT.LAB (C:2.0)
Via this
Submission | ESAOTE
IMT.LAB (C:1.0)
(K043360) | SonoMetric Health
SonoCalc
(K030223) | Philips Medical
Systems
QLAB (K021966) | |------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | The IMT.LAB
software is a
Windows 2000/XP
software package
to be used on a
personal computer
for the automatic
measurement of the
intima media
thickness of the
carotid artery from
video images
obtained from
Esaote ultrasound
systems. | The IMT.LAB
software is a
Windows 2000/XP
software package
to be used on a
personal computer
for the automatic
measurement of the
intima media
thickness of the
carotid artery from
video images
obtained from
Esaote ultrasound
systems. | The SonoCalc
software is a
Windows-based
application
program used on a
personal computer
for the automatic
measurement of the
intima media
thickness of the
carotid artery from
images obtained
from ultrasound
systems | The Q LAB
Quantification
software is a
Windows
2000/Windows XP
software
application
package. It is
designed to view
and quantify image
data acquired on
Philips Medical
Systems
ultrasound
products. | | Image source | Ultrasound images | Ultrasound images | Ultrasound images | Ultrasound images | | Operating
environment,
system and
hardware | Stand alone
application
program for use on
a personal
computer with
Microsoft
Windows | Stand alone
application
program for use on
a personal
computer with
Microsoft
Windows | Stand alone
application
program for use on
a personal
computer with
Microsoft
Windows | Stand alone
application
program for use on
a personal
computer with
Microsoft
Windows | | Image format | DICOM, JPEG and
Windows BMP | DICOM, JPEG and
Windows BMP | JPEG and
Windows BMP | AVI and Windows
BMP | | Image storage
and report
generation | Yes | Yes | Yes | Yes | | Automatic
distance
measurement of
the intima media
thickness of an
artery | Yes | Yes | Yes | Yes | | | ESAOTE
IMT.LAB (C:2.0)
Via this
Submission | ESAOTE
IMT.LAB (C:1.0)
(K043360) | SonoMetric Health
SonoCalc
(K030223) | Philips Medical
Systems
QLAB (K021966) | | Classification | 90LLZ | 90LLZ | 90LLZ | 90LLZ | | | 892.2050 | 892.2050 | 892.2050 | 892.2050 | | Image | JPEG | JPEG | JPEG | None | | Compression | Loss-less | Loss-less | Lossy | | | | | | | Lossy | {3}------------------------------------------------ # 510(k) Summary IMT.LAB Esaote Europe {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with the text "MINISTRY OF HEALTH & KL" arranged in a circular fashion on the left side. To the right of the text, there are three stylized, curved lines that appear to be stacked on top of each other. The lines are thick and black, and they create a sense of movement or flow. The overall design is simple and modern, with a focus on clean lines and a minimalist aesthetic. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 ## OCT 3 1 2006 Esaote Europe, B.V. % Ms. Carri Graham The Anson Group 1460 N Meridian St., Ste 150 CARMEL IN 46032 Re: K062598 Trade/Device Name: IMT. LAB SOFTWARE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and IYO Dated: August 25, 2006 Received: September 1, 2006 Dear Ms. Graham: 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 Cost retic Act (Act) that do not require approval of a premarket approval application (PMA). You maxi. 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 affective 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/4/Picture/10 description: The image is a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1906-2006" are displayed. Below the letters, the word "Centennial" is written in cursive. Three dots are arranged in a horizontal line at the bottom of the logo. Protecting and Promoting Public Health {5}------------------------------------------------ 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 vours. Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Ko 2598 Device Name: IMT.LAB Software Indications for Use: The IMT.LAB software is a Windows 2000/XP software application package to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote ultrasound systems. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David R. Lyman Division Sign-Off) Orvision of Reproductive, Abdominal, · adiological Devices Erik) Number - Page 1 of 1 9 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K062598](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K062598) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com