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FDA 510(k)

TOPOGRAPHIC IMAGING MARKER

K-Number: K962606 · 1996-08-07

ApplicantI.Z.I. Medical Products Corp.
Decision Date1996-08-07
Product CodeJAA
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 1996-08-07 under 510(k) number K962606. The device is classified under product code JAA. 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 1996-08-07. The listed applicant is I.Z.I. Medical Products Corp.. The 510(k) number is K962606.

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

TOPOGRAPHIC IMAGING MARKER received FDA 510(k) clearance on 1996-08-07, under 510(k) number K962606.

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 JAA.

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 MARKERK990298TOPOGRAPHIC IMAGING MARKERK964972SHADOWFORM

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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