FDA 510(k)

KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600

K-Number: K983905 · 1999-01-25

Decision Date1999-01-25

Product CodeLMC

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600 is the device name listed in this FDA 510(k) record. The listed applicant is Eastman Kodak Company. It received FDA 510(k) clearance on 1999-01-25 under 510(k) number K983905. The device is classified under product code LMC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600?

KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600 is a medical device that received FDA 510(k) clearance on 1999-01-25. The listed applicant is Eastman Kodak Company. The 510(k) number is K983905.

When did KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600 receive FDA 510(k) clearance?

KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600 received FDA 510(k) clearance on 1999-01-25, under 510(k) number K983905.

Who is the listed applicant for KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600?

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

What is the FDA product code for KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600?

The FDA product code for KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600 is LMC.

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Other records listing Eastman Kodak Company as applicant

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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.