FDA 510(k)

DFS-2100

K-Number: K932760 · 1994-10-20

Decision Date1994-10-20

Product CodeLMA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DFS-2100 is the device name listed in this FDA 510(k) record. The listed applicant is Dba Systems, Inc.. It received FDA 510(k) clearance on 1994-10-20 under 510(k) number K932760. The device is classified under product code LMA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DFS-2100?

DFS-2100 is a medical device that received FDA 510(k) clearance on 1994-10-20. The listed applicant is Dba Systems, Inc.. The 510(k) number is K932760.

When did DFS-2100 receive FDA 510(k) clearance?

DFS-2100 received FDA 510(k) clearance on 1994-10-20, under 510(k) number K932760.

Who is the listed applicant for DFS-2100?

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

What is the FDA product code for DFS-2100?

The FDA product code for DFS-2100 is LMA.

Other records listing Dba Systems, Inc. as applicant

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.

K992467IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.