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FDA 510(k)

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)

K-Number: K230611 · 2023-07-13

ApplicantXstrahl, Ltd.
Decision Date2023-07-13
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) is a medical device manufactured by Xstrahl, Ltd.. It received FDA 510(k) clearance on 2023-07-13 under approval number K230611. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)?

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) is a medical device that received FDA 510(k) clearance on 2023-07-13. It is manufactured by Xstrahl, Ltd.. The 510(k) number is K230611.

When was X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) approved by the FDA?

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) received FDA 510(k) clearance on 2023-07-13, under approval number K230611.

What company makes X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)?

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) is manufactured by Xstrahl, Ltd..

What is the FDA product code for X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)?

The FDA product code for X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) is JAD.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Other Devices by Xstrahl, Ltd.

K172080Photoelectric Therapy System K240671XBeam (v2)

Related Devices (Code: JAD)

K162568INTRABEAM 600Carl Zeiss Meditec, AG K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. K172080Photoelectric Therapy SystemXstrahl, Ltd. K173425SRT-100+Sensus Healthcare, Inc. K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc. K182641Sensus IORT SystemSensus Healthcare, 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.

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