FDA 510(k)

DIGITIZER, MODEL # 3-000A-1518

K-Number: K922619 · 1992-07-01

Decision Date1992-07-01

Product CodeIZH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DIGITIZER, MODEL # 3-000A-1518 is the device name listed in this FDA 510(k) record. The listed applicant is Lorad Medical Systems, Inc.. It received FDA 510(k) clearance on 1992-07-01 under 510(k) number K922619. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITIZER, MODEL # 3-000A-1518?

DIGITIZER, MODEL # 3-000A-1518 is a medical device that received FDA 510(k) clearance on 1992-07-01. The listed applicant is Lorad Medical Systems, Inc.. The 510(k) number is K922619.

When did DIGITIZER, MODEL # 3-000A-1518 receive FDA 510(k) clearance?

DIGITIZER, MODEL # 3-000A-1518 received FDA 510(k) clearance on 1992-07-01, under 510(k) number K922619.

Who is the listed applicant for DIGITIZER, MODEL # 3-000A-1518?

The FDA 510(k) record lists Lorad Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITIZER, MODEL # 3-000A-1518?

The FDA product code for DIGITIZER, MODEL # 3-000A-1518 is IZH.

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Other records listing Lorad Medical Systems, Inc. as applicant

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Related Devices (Code: IZH)

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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.