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FDA 510(k)

THE IMAGE/R

K-Number: K862294 · 1987-01-14

ApplicantQuantum Diagnostics, Ltd.
Decision Date1987-01-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE IMAGE/R is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Diagnostics, Ltd.. It received FDA 510(k) clearance on 1987-01-14 under 510(k) number K862294. 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 THE IMAGE/R?

THE IMAGE/R is a medical device that received FDA 510(k) clearance on 1987-01-14. The listed applicant is Quantum Diagnostics, Ltd.. The 510(k) number is K862294.

When did THE IMAGE/R receive FDA 510(k) clearance?

THE IMAGE/R received FDA 510(k) clearance on 1987-01-14, under 510(k) number K862294.

Who is the listed applicant for THE IMAGE/R?

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

What is the FDA product code for THE IMAGE/R?

The FDA product code for THE IMAGE/R is LLZ.

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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

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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