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FDA 510(k)

Cianna Medical SAVI Scout Reflector and SAVI Scout System

K-Number: K181007 · 2018-08-02

ApplicantCianna Medical, Inc.
Decision Date2018-08-02
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cianna Medical SAVI Scout Reflector and SAVI Scout System is a medical device manufactured by Cianna Medical, Inc.. It received FDA 510(k) clearance on 2018-08-02 under approval number K181007. 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 Cianna Medical SAVI Scout Reflector and SAVI Scout System?

Cianna Medical SAVI Scout Reflector and SAVI Scout System is a medical device that received FDA 510(k) clearance on 2018-08-02. It is manufactured by Cianna Medical, Inc.. The 510(k) number is K181007.

When was Cianna Medical SAVI Scout Reflector and SAVI Scout System approved by the FDA?

Cianna Medical SAVI Scout Reflector and SAVI Scout System received FDA 510(k) clearance on 2018-08-02, under approval number K181007.

What company makes Cianna Medical SAVI Scout Reflector and SAVI Scout System?

Cianna Medical SAVI Scout Reflector and SAVI Scout System is manufactured by Cianna Medical, Inc..

What is the FDA product code for Cianna Medical SAVI Scout Reflector and SAVI Scout System?

The FDA product code for Cianna Medical SAVI Scout Reflector and SAVI Scout System is NEU.

Related Clinical Trials

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Cianna Medical, Inc.

K161507Cianna Medical SAVI Scout Reflector and SAVI Scout System K171767Cianna Medical SAVI Scout Reflector and SAVI Scout 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.

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