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FDA 510(k)

PERFORMA STEREO

K-Number: K023864 · 2003-01-09

ApplicantInstrumentarium Corp. Imaging Division
Decision Date2003-01-09
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PERFORMA STEREO is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Corp. Imaging Division. It received FDA 510(k) clearance on 2003-01-09 under 510(k) number K023864. 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 PERFORMA STEREO?

PERFORMA STEREO is a medical device that received FDA 510(k) clearance on 2003-01-09. The listed applicant is Instrumentarium Corp. Imaging Division. The 510(k) number is K023864.

When did PERFORMA STEREO receive FDA 510(k) clearance?

PERFORMA STEREO received FDA 510(k) clearance on 2003-01-09, under 510(k) number K023864.

Who is the listed applicant for PERFORMA STEREO?

The FDA 510(k) record lists Instrumentarium Corp. Imaging Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERFORMA STEREO?

The FDA product code for PERFORMA STEREO is IZH.

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Other records listing Instrumentarium Corp. Imaging Division 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.

K043612ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200DK022275DELTA 32; DELTA 32 TACT

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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