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FDA 510(k)

DIGITAL IMAGE ANALYSIS SYSTEM

K-Number: K962153 · 1997-01-17

ApplicantUniversity of Washington
Decision Date1997-01-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL IMAGE ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is University of Washington. It received FDA 510(k) clearance on 1997-01-17 under 510(k) number K962153. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL IMAGE ANALYSIS SYSTEM?

DIGITAL IMAGE ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-17. The listed applicant is University of Washington. The 510(k) number is K962153.

When did DIGITAL IMAGE ANALYSIS SYSTEM receive FDA 510(k) clearance?

DIGITAL IMAGE ANALYSIS SYSTEM received FDA 510(k) clearance on 1997-01-17, under 510(k) number K962153.

Who is the listed applicant for DIGITAL IMAGE ANALYSIS SYSTEM?

The FDA 510(k) record lists University of Washington as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL IMAGE ANALYSIS SYSTEM?

The FDA product code for DIGITAL IMAGE ANALYSIS SYSTEM is LLZ.

Related Clinical Trials

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Other records listing University of Washington 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.

K812213AUTOMATED ELECTROCAUTERY SYSTEM

Related Devices (Code: LLZ)

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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Official Source

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

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