Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GIOTTO IMAGE

K-Number: K012953 · 2001-11-30

ApplicantMedx, Inc.
Decision Date2001-11-30
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GIOTTO IMAGE is the device name listed in this FDA 510(k) record. The listed applicant is Medx, Inc.. It received FDA 510(k) clearance on 2001-11-30 under 510(k) number K012953. 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 GIOTTO IMAGE?

GIOTTO IMAGE is a medical device that received FDA 510(k) clearance on 2001-11-30. The listed applicant is Medx, Inc.. The 510(k) number is K012953.

When did GIOTTO IMAGE receive FDA 510(k) clearance?

GIOTTO IMAGE received FDA 510(k) clearance on 2001-11-30, under 510(k) number K012953.

Who is the listed applicant for GIOTTO IMAGE?

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

What is the FDA product code for GIOTTO IMAGE?

The FDA product code for GIOTTO IMAGE is IZH.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medx, 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.

K082581C-QUESTK073456T-QUEST SYSTEMK041840MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEMK993893MEDX INTECAM INTERFACEK884661D-SCOPE IIIK872127D-SCOPE II AND D-SCOPE IIC

View all 8 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑