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FDA 510(k)

REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY

K-Number: K840364 · 1984-03-19

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1984-03-19
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K840364. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY?

REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K840364.

When did REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY receive FDA 510(k) clearance?

REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY received FDA 510(k) clearance on 1984-03-19, under 510(k) number K840364.

Who is the listed applicant for REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY?

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

What is the FDA product code for REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY?

The FDA product code for REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY is JAA.

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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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