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FDA 510(k)

DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI

K-Number: K080351 · 2008-04-22

ApplicantDexela, Ltd.
Decision Date2008-04-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI is the device name listed in this FDA 510(k) record. The listed applicant is Dexela, Ltd.. It received FDA 510(k) clearance on 2008-04-22 under 510(k) number K080351. 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 DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI?

DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI is a medical device that received FDA 510(k) clearance on 2008-04-22. The listed applicant is Dexela, Ltd.. The 510(k) number is K080351.

When did DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI receive FDA 510(k) clearance?

DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI received FDA 510(k) clearance on 2008-04-22, under 510(k) number K080351.

Who is the listed applicant for DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI?

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

What is the FDA product code for DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI?

The FDA product code for DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI is LLZ.

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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.

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