← Product Code [IYO](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO) · K963807 # TOMTEC ECHO-SCAN (K963807) _Tomtec Imaging Systems, Inc. · IYO · Dec 18, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K963807 ## Device Facts - **Applicant:** Tomtec Imaging Systems, Inc. - **Product Code:** [IYO](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO.md) - **Decision Date:** Dec 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1560 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The TomTec Echo-Scan is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The Echo-Scan acquires sets of 2D images and stores them digitally in the TomTec standard 3D image file format for subsequent 3D tomographic reconstruction and surface rendering with either the Echo-Scan or Echo-View. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology. The TomTec Freehand Scanning Device is intended for acquiring a sequence of conventional 2D ultrasound images with transducer position recorded for each image acquired. The resulting image data set is intended for storage in the TomTec standard 3D image file format for subsequent 3D tomographic image reconstruction. ## Device Story Add-on accessory for existing ultrasound systems; acquires, analyzes, stores, and retrieves 2D ultrasound images to generate 3D/4D reconstructions. Freehand scanning component uses a coordinate tracking system to record transducer spatial position (six degrees of freedom) during manual sweeping. System digitizes 2D image slices; stores data in proprietary 3D file format. Used in clinical settings (cardiology, radiology, etc.) by clinicians. Output includes 3D tomographic reconstructions and surface renderings; assists clinicians in visualizing anatomical volumes. Benefits include enhanced spatial visualization of ultrasound data for diagnostic assessment. ## Clinical Evidence Bench testing only. Software validation performed at module and system levels per internal protocols. No clinical data provided. ## Technological Characteristics Intel-based computer system; Microsoft DOS/Windows OS. Proprietary image digitizer circuit board. Coordinate tracking system for 6-degree-of-freedom spatial positioning. Connectivity: add-on accessory to ultrasound systems. Software-based image processing for 3D/4D reconstruction and surface rendering. ## Regulatory Identification An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. ## Special Controls *Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. ## Predicate Devices - TomTec Echo-Scan ([K941322](/device/K941322.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} IOMTEC September 20, 1996 DEC 18 1996 K963807 # 510(k) Summary TomTec Echo-Scan with Freehand Scanning ## Name and Address TomTec Imaging Systems, Inc. 4775 Walnut Street, Suite C Boulder, Colorado 80301 ## Contact Person Kevin Morningstar Director, Regulatory Affairs & Quality Assurance Phone (303) 473 2285 fax (303) 545 0114 ## Common, Classification & Proprietary Names Common Name: Digital Ultrasound Image Analysis System Classification Name: Ultrasonic Pulsed Echo Imaging System Proprietary Name: TomTec Echo-Scan ## Predicate Device TomTec Echo-Scan K941322, dated July 27, 1995 ## Device Description The TomTec Echo-Scan is a high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards. It incorporates a proprietary image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The TomTec Freehand Scanning Device records ultrasound transducer spatial position in six degrees of freedom during use. 2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is swept across the patient scan site. TomTec Imaging Systems, Inc. 4775 Walnut Street • Suite C • Boulder, CO • 80301 • Phone: 303/545-9000 • Toll-free: 800/922-6543 • Fax: 303/545 {1} # Intended Use The TomTec Echo-Scan is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The Echo-Scan acquires sets of 2D images and stores them digitally in the TomTec standard 3D image file format for subsequent 3D tomographic reconstruction and surface rendering with either the Echo-Scan or Echo-View. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology. The TomTec Freehand Scanning Device is intended for acquiring a sequence of conventional 2D ultrasound images with transducer position recorded for each image acquired. The resulting image data set is intended for storage in the TomTec standard 3D image file format for subsequent 3D tomographic image reconstruction. # Technological Characteristics Comparison The Echo-Scan system has been modified to add freehand scanning. This change expands the selection of image acquisition accessory devices (or probe carriage devices) available to control and/or monitor ultrasound transducer movement during image acquisition. With freehand scanning, the user scans a patient with the transducer held in the hand as he customarily would. This is made possible by using a coordinate tracking system. The coordinate tracking system provides spatial coordinates which can be encoded for each 2D image acquired as the transducer is moved. # Test Discussion Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. # Test Conclusions Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally conforms to the system performance specifications. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K963807](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K963807) **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. 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