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

FDA 510(k)

RFID Localization System

K-Number: K193189 · 2020-05-06

ApplicantHealth Beacons, Inc.
Decision Date2020-05-06
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RFID Localization System is a medical device manufactured by Health Beacons, Inc.. It received FDA 510(k) clearance on 2020-05-06 under approval number K193189. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RFID Localization System?

RFID Localization System is a medical device that received FDA 510(k) clearance on 2020-05-06. It is manufactured by Health Beacons, Inc.. The 510(k) number is K193189.

When was RFID Localization System approved by the FDA?

RFID Localization System received FDA 510(k) clearance on 2020-05-06, under approval number K193189.

What company makes RFID Localization System?

RFID Localization System is manufactured by Health Beacons, Inc..

What is the FDA product code for RFID Localization System?

The FDA product code for RFID Localization System is NEU.

Related Clinical Trials

NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT06004440 Real World Registry for Use of the Ion Endoluminal System ACTIVE_NOT_RECRUITING NCT07281222 Evaluation of the FYNA Research OPM MEG Device for Locating Epileptic Foci as Part of Pre-surgical Assessment of Epilepsy NOT_YET_RECRUITING NCT07368829 AI-Driven Autonomous Registration in Robotic Bronchoscopy RECRUITING

Other Devices by Health Beacons, Inc.

K163667RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) K1816925cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) K190932RFID Localization System

Related Devices (Code: NEU)

K152510UltraCor Twirl Breast Tissue MarkerBard Peripheral Vascular, Inc. K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. K171767Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. K170026Radiopaque Tissue MarkerViscus Biologics, LLC K170905Star Tissue MarkerScion Medical Technologies, LLC

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.

↑