FDA 510(k)

Biopsy Positioner

K-Number: K191495 · 2019-07-03

Decision Date2019-07-03

Product CodeIZH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Biopsy Positioner is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-07-03 under approval number K191495. 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 Biopsy Positioner?

Biopsy Positioner is a medical device that received FDA 510(k) clearance on 2019-07-03. It is manufactured by Fujifilm Corporation. The 510(k) number is K191495.

When was Biopsy Positioner approved by the FDA?

Biopsy Positioner received FDA 510(k) clearance on 2019-07-03, under approval number K191495.

What company makes Biopsy Positioner?

Biopsy Positioner is manufactured by Fujifilm Corporation.

What is the FDA product code for Biopsy Positioner?

The FDA product code for Biopsy Positioner is IZH.

Other Devices by Fujifilm Corporation

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Related Devices (Code: IZH)

K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic K161920Comfort CoverPrecision Dynamics Corporation K153486Affirm Prone Biopsy SystemHologic, Inc. K202294Affirm Contrast BiopsyHologic, Inc. K203509SMART FINDERIms Giotto S.P.A.

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.