TEEC Transducer

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Teec (Transesophageal Echocardiography) Transducer

510(k) Number

K883546 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K843130 Active Cleared 6 Dec 1984

• Annular Array Scanhead

  Class II

  FDA 510(k) K871856 Active Cleared 28 Aug 1987

• Mark 500 Ultrasouond System

  Class II

  FDA 510(k) K820364 Active Cleared 26 Mar 1982

• Vitastat Ecg-1/Ecg-3 Electrocardiograph

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  FDA 510(k) K803309 Active Cleared 16 Jan 1981

• Access Scanheadss

  Class II

  FDA 510(k) K840953 Active Cleared 15 Jun 1984

• Ultramark 9 Ultrasound System (Um 9)

  Class II

  FDA 510(k) K903603 Active Cleared 26 Feb 1991

See all devices from Advanced Technology Laboratories, Inc. →

• Is the TEEC Transducer probe designed for single-use or can it be reused after proper cleaning and sterilization?

  The TEEC Transducer is explicitly described as a reusable medical instrument. Since it is intended for use in sterile conditions—particularly in radiology settings—it must be cleaned and sterilized between uses to maintain safety and performance. The manufacturer, Advanced Technology Laboratories, Inc., has not provided specific sterilization instructions in the provided data, but the reusable classification implies compliance with standard medical device reprocessing protocols.

• What types of cardiac assessments can this device help visualize, and how does it differ from other imaging methods?

  The TEEC Transducer emits ultrasonic sound waves through the esophagus to create detailed images of cardiac structures, allowing clinicians to evaluate heart function and pathology with high precision. Unlike transthoracic echocardiography (which uses sound waves transmitted through the chest wall), this method provides clearer images of the heart’s internal details due to its proximity to the heart via the esophagus. It is particularly useful for assessing complex conditions like valve disorders, congenital heart defects, or pericardial diseases.

• How was this device’s regulatory approval process handled, and what does the ‘Radiology Advisory Committee’ classification mean?

  The TEEC Transducer received FDA clearance via a 510(k) submission (K883546) in 1988 under the Radiology Advisory Committee (RA). This classification means the device was reviewed by the Radiology panel to ensure it met safety and effectiveness standards for diagnostic imaging tools in radiology settings. The ‘substantially equivalent’ (SESE) decision indicates it was deemed comparable to a legally marketed predicate device at the time of clearance, without requiring third-party review.

• What are the key differences between this TEEC Transducer and other transesophageal echocardiography probes on the market?

  While the provided data does not list competing models, the TEEC Transducer is notable for its reusable design and FDA clearance under the Radiology Advisory Committee, which may influence its intended clinical workflows. Unlike some single-use alternatives, this probe requires proper sterilization between patients, which could impact cost and logistical considerations in healthcare settings. Its classification under FDA Product Code IYO (Transesophageal Echocardiography Probe) also aligns it with devices used for detailed cardiac imaging in radiology departments.