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FDA 510(k)

TOPOGRAPHIC IMAGING MARKER

K-Number: K990298 · 1999-03-03

ApplicantI.Z.I. Medical Products Corp.
Decision Date1999-03-03
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOPOGRAPHIC IMAGING MARKER is the device name listed in this FDA 510(k) record. The listed applicant is I.Z.I. Medical Products Corp.. It received FDA 510(k) clearance on 1999-03-03 under 510(k) number K990298. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOPOGRAPHIC IMAGING MARKER?

TOPOGRAPHIC IMAGING MARKER is a medical device that received FDA 510(k) clearance on 1999-03-03. The listed applicant is I.Z.I. Medical Products Corp.. The 510(k) number is K990298.

When did TOPOGRAPHIC IMAGING MARKER receive FDA 510(k) clearance?

TOPOGRAPHIC IMAGING MARKER received FDA 510(k) clearance on 1999-03-03, under 510(k) number K990298.

Who is the listed applicant for TOPOGRAPHIC IMAGING MARKER?

The FDA 510(k) record lists I.Z.I. Medical Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOPOGRAPHIC IMAGING MARKER?

The FDA product code for TOPOGRAPHIC IMAGING MARKER is KPR.

Related Clinical Trials

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.

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Other records listing I.Z.I. Medical Products Corp. 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.

K990242TOPOGRAPHIC IMAGING MARKERK964972SHADOWFORMK962606TOPOGRAPHIC IMAGING MARKER

Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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