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FDA 510(k)

ULTRA IMAGE AND ULTRA SCAN

K-Number: K981028 · 1998-08-21

ApplicantSonotech, Inc.
Decision Date1998-08-21
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRA IMAGE AND ULTRA SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Sonotech, Inc.. It received FDA 510(k) clearance on 1998-08-21 under 510(k) number K981028. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA IMAGE AND ULTRA SCAN?

ULTRA IMAGE AND ULTRA SCAN is a medical device that received FDA 510(k) clearance on 1998-08-21. The listed applicant is Sonotech, Inc.. The 510(k) number is K981028.

When did ULTRA IMAGE AND ULTRA SCAN receive FDA 510(k) clearance?

ULTRA IMAGE AND ULTRA SCAN received FDA 510(k) clearance on 1998-08-21, under 510(k) number K981028.

Who is the listed applicant for ULTRA IMAGE AND ULTRA SCAN?

The FDA 510(k) record lists Sonotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRA IMAGE AND ULTRA SCAN?

The FDA product code for ULTRA IMAGE AND ULTRA SCAN is ITX.

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Other records listing Sonotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: ITX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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