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FDA 510(k)

DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA

K-Number: K852284 · 1985-11-14

ApplicantDigirad Corp.
Decision Date1985-11-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA is the device name listed in this FDA 510(k) record. The listed applicant is Digirad Corp.. It received FDA 510(k) clearance on 1985-11-14 under 510(k) number K852284. 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 DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA?

DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA is a medical device that received FDA 510(k) clearance on 1985-11-14. The listed applicant is Digirad Corp.. The 510(k) number is K852284.

When did DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA receive FDA 510(k) clearance?

DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA received FDA 510(k) clearance on 1985-11-14, under 510(k) number K852284.

Who is the listed applicant for DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA?

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

What is the FDA product code for DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA?

The FDA product code for DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA is LLZ.

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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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