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FDA 510(k)

System, Applicator, Radionuclide, Remote Controlled

K-Number: K170203 · 2017-06-01

ApplicantKobold, LLC
Decision Date2017-06-01
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

System, Applicator, Radionuclide, Remote Controlled is a medical device manufactured by Kobold, LLC. It received FDA 510(k) clearance on 2017-06-01 under approval number K170203. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the System, Applicator, Radionuclide, Remote Controlled?

System, Applicator, Radionuclide, Remote Controlled is a medical device that received FDA 510(k) clearance on 2017-06-01. It is manufactured by Kobold, LLC. The 510(k) number is K170203.

When was System, Applicator, Radionuclide, Remote Controlled approved by the FDA?

System, Applicator, Radionuclide, Remote Controlled received FDA 510(k) clearance on 2017-06-01, under approval number K170203.

What company makes System, Applicator, Radionuclide, Remote Controlled?

System, Applicator, Radionuclide, Remote Controlled is manufactured by Kobold, LLC.

What is the FDA product code for System, Applicator, Radionuclide, Remote Controlled?

The FDA product code for System, Applicator, Radionuclide, Remote Controlled is JAQ.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Kobold, LLC

K160610Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set

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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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