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FDA 510(k)

BIOPSY-DIGIT

K-Number: K990192 · 1999-03-12

ApplicantSitco, Inc.
Decision Date1999-03-12
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOPSY-DIGIT is the device name listed in this FDA 510(k) record. The listed applicant is Sitco, Inc.. It received FDA 510(k) clearance on 1999-03-12 under 510(k) number K990192. 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-DIGIT?

BIOPSY-DIGIT is a medical device that received FDA 510(k) clearance on 1999-03-12. The listed applicant is Sitco, Inc.. The 510(k) number is K990192.

When did BIOPSY-DIGIT receive FDA 510(k) clearance?

BIOPSY-DIGIT received FDA 510(k) clearance on 1999-03-12, under 510(k) number K990192.

Who is the listed applicant for BIOPSY-DIGIT?

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

What is the FDA product code for BIOPSY-DIGIT?

The FDA product code for BIOPSY-DIGIT is IZH.

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Other records listing Sitco, 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.

K982049BIOPSY MK973856GIOTTO HTK953255NUQUEST NUCLEAR MEDICINE COMPUTER

Related Devices (Code: IZH)

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, Inc.

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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