Who is the manufacturer of SONATA 3-D IMAGING ACCESSORY, MODEL 3DS?

Tetrad Corp. filed the 510(k) submission for SONATA 3-D IMAGING ACCESSORY, MODEL 3DS (K042620).

What is the FDA product code for SONATA 3-D IMAGING ACCESSORY, MODEL 3DS?

IYO. It is classified under 21 CFR 892.1560 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SONATA 3-D IMAGING ACCESSORY, MODEL 3DS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SONATA 3-D IMAGING ACCESSORY, MODEL 3DS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SONATA 3-D IMAGING ACCESSORY, MODEL 3DS

Q: What are the predicate devices for SONATA 3-D IMAGING ACCESSORY, MODEL 3DS?

Sonora Medical Systems Baby Face (K994385).

K042620 · Tetrad Corp. · IYO · Dec 23, 2004 · Radiology

Device Facts

Record ID	K042620
Device Name	SONATA 3-D IMAGING ACCESSORY, MODEL 3DS
Applicant	Tetrad Corp.
Product Code	IYO · Radiology
Decision Date	Dec 23, 2004
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1560
Device Class	Class 2

Intended Use

Intended to be used by or under the direction of a physician for 3-D clinical imaging in fetal applications. This is only to be used in conjunction with the 2300 Ultrasound Imaging System marketed under the model name 'Sonata' or 'Telocin', labeled as 2300 Ultrasound Imaging System manufactured by Tetrad Corporation.

Device Story

Sonata 3-D is a visualization tool designed to add 3-D imaging capabilities to the Tetrad 2300 Ultrasound Imaging System. The device acquires volume data via free-hand scanning, transforming 2-D ultrasound inputs into a Cartesian volume. Processing includes surface rendering and segmentation of structures from 3-D data. The system operates on a Pentium IV 2.8 GHz platform using a digital frame grabber with real-time memory mapping. It is intended for use by or under the direction of a physician in clinical settings. The output is visualized by the healthcare provider to assist in fetal imaging; the device does not perform quantitative evaluations, measurements, or calculations.

Clinical Evidence

No clinical data provided. The submission relies on technological comparison and bench-level functional equivalence to the predicate device.

Technological Characteristics

Pentium IV 2.8 GHz processor; digital frame grabber with real-time RAM memory mapping; system keyboard control. Software performs volume data acquisition, Cartesian volume transformation, surface rendering, and structure segmentation. No quantitative measurement capabilities. Standalone visualization tool for integration with Tetrad 2300 Ultrasound Imaging System.

Indications for Use

Indicated for 3-D clinical imaging in fetal applications. Intended for use by or under the direction of a physician.

Regulatory Classification

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

Sonora Medical Systems Baby Face (K994385)

Related Devices

K020068 — SONOREAL 3D SYSTEM · Bio Medi Com · Mar 4, 2002
K012084 — SONOREAL 3D · Bio Medi Com · Sep 26, 2001
K023473 — SONOREAL 3D · Bio Medi Com · Nov 20, 2002
K994385 — BABY FACE · Sonora Medical Systems · Mar 16, 2000
K053306 — IVIEW · Ondemandsoft · Apr 19, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ K042620 Page 1 of 2 510(k) Summary Sonata 3-D Tetrad Corporation DEC 2 3 2004 ### 510(k) Summary The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21 CFR 807.92(a). 807.92(a)(1) Submitter Information Dennis R. Dietz, Chief Technical Officer Tetrad Corporation 357 Inverness Drive South Unit A Englewood, Colorado 80112 Phone: 303-754-2326 303-754-2329 Fax: Contact person: Dennis R. Dietz Date: September 7, 2004 807.92(a)(2) Trade Name: Sonata 3-D Common Name: Digital Ultrasound Imaging System Classifiction Name: System, Imaging, Pulsed Echo, Ultrasonic Classification Number: 90IYO 807(a)(3) #### Predicate Device Sonora Medical Systems Baby Face K994385 Additional substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table. {1}------------------------------------------------ K042626 Page 2 of 2 #### 510(k) Summary Sonata 3-D Tetrad Corporation · · · · · · · · · · | | Sonora Medical Systems Baby Face K1722606 | Tetrad Corporation Sonata 3-D | |-------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | Basic Function | Adds 3-D imaging capability to commercial 2-D ultrasound imaging systems. | Adds 3-D imaging capability to commercial 2-D ultrasound imaging system. | | Hardware | Cyrix 266 MHz | Pentium IV 2.8 GHz | | | Frame Grabber (VHS/S-VHS Input) | Frame Grabber digital via real time memory mapping in RAM | | | Video Out | Video out via Sonata System | | | Hand held controller | System keyboard control | | | | | | Software features | Volume data acquisition w/frame grabbing of video data b/w while using a Gyroscopic sensor system. | Volume data acquisition w/frame grabbing of digital data b/w while scanning free-hand. | | | Conditioning and transformation of the acquired data into a Cartesian volume | Conditioning and transformation of the acquired data into a Cartesian volume | | | Surface rendering | Surface rendering | | | Segmentation of structures from 3-D data. | Segmentation of structures from 3-D data. | | | No quantitative evaluation. | No quantitative evaluation. | | | No measurements or calculations | No measurements or calculations | ## Comparison Chart for Substantial Equivalence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # DEC 2 3 2004 Dennis R. Dietz, Ph.D. Chief Technical Officer Tetrad Corporation 357 Inverness Drive South, Unit A ENGLEWOOD CO 80112 Re: K042620 Trade/Device Name: Sonata 3-D Visualization Tool Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: November 18, 2004 Received: December 7, 2004 Dear Dr. Dietz: We have reviewed your Section 510(k) premarket notification of intent to market the device is a We have revewed your Section 510(t) promanted in the indications for use stated in above and have decemined the devices marketed in interstate commerce prior to the enclosure) to legally marketed predicato device Amendments, or to devices that have been May 28, 1976, the ellacinem and of the Federal Food, Drug, and Cosmetic Act (Act) that the feclassified in accordatics with the proval application (PMA). You may, therefore, market the Art do not require approval of a premaince approval and (The Act. The general controls provisions of the Act. device, subject to the general controls 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 if your device is classince (see above) into entrols. Existing major regulations affecting your Approval), It may be subject to such adultions, Title 21, Parts 800 to 898. In addition, FDA device can be found in the Couverning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mat I DA s issualled of a sassamments of the requirements of the Act or any FDA has made a determination that your device complies with other requirements o F DA has made a decemination that your as a more of the Federal agencies. You must comply with all the Federal statues and regulations administer of one issues of the Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Fart 801); good mandracting product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) 1 ms letter will and your your finding of substantial equivalence of your device to a legally premarked notined.com "cresults 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 11 you dostro specifice of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Anot process not regarment information on your responsibilities under the Act from the 807: 77). " Coamin Purers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.httml Sincerely yours, Nancy C. brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K042620 Device Name: Sonata 3-D Visualization Tool Indications for Use: Intended to be used by or under the direction of a physician for 3-20 Inical imaging in fetal applications. This is only to be used in conjunction with the 2300 Ultrasound Imaging in rotar appensarketed under the model name 'Sonata' or 'Telocin', Iabeled as 2300 Ultrasound Imaging System manufactured by Tetrad Corporation. Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David le Segura Page 1 of 1 (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 14210 T 510(k) Number _