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)

FTI 100 MEDICAL THERMAL IMAGER

K-Number: K862416 · 1986-07-01

ApplicantParexel Intl. Corp.
Decision Date1986-07-01
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FTI 100 MEDICAL THERMAL IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Parexel Intl. Corp.. It received FDA 510(k) clearance on 1986-07-01 under 510(k) number K862416. The device is classified under product code LMC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FTI 100 MEDICAL THERMAL IMAGER?

FTI 100 MEDICAL THERMAL IMAGER is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Parexel Intl. Corp.. The 510(k) number is K862416.

When did FTI 100 MEDICAL THERMAL IMAGER receive FDA 510(k) clearance?

FTI 100 MEDICAL THERMAL IMAGER received FDA 510(k) clearance on 1986-07-01, under 510(k) number K862416.

Who is the listed applicant for FTI 100 MEDICAL THERMAL IMAGER?

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

What is the FDA product code for FTI 100 MEDICAL THERMAL IMAGER?

The FDA product code for FTI 100 MEDICAL THERMAL IMAGER is LMC.

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 Parexel Intl. 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.

K900385ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGEK904901L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUCK904902SMA 26 TRANSDUCERK884800ACTA GENOS ELECTROCARDIOGRAPHK862414FUJI CR IMAGING PLATEK864519PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)

View all 14 devices →

Related Devices (Code: LMC)

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.

K111566DRYVIEW CHROMA IMAGING SYSTEMCarestream Health, Inc.K092280CYPHER DICOM PRINT SOLUTIONVirtual Imaging, Inc.K090469CARESTREAM DRYVIEW 5850 LASER IMAGERCarestream Health, Inc.K083522SONY UP-DF750 DIGITAL FILM IMAGERSony Electronics, Inc.K081637LASER IMAGER DRYPRO MODEL 873Konica Minolta Medical & Graphic, Inc.K072680DRYSTAR AXYS, MODEL EYZ4EAgfa Healthcare Corporation

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.

↑