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)

CARIESCAN PRO

K-Number: K090598 · 2009-12-15

ApplicantCariescan , Ltd.
Decision Date2009-12-15
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARIESCAN PRO is the device name listed in this FDA 510(k) record. The listed applicant is Cariescan , Ltd.. It received FDA 510(k) clearance on 2009-12-15 under 510(k) number K090598. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARIESCAN PRO?

CARIESCAN PRO is a medical device that received FDA 510(k) clearance on 2009-12-15. The listed applicant is Cariescan , Ltd.. The 510(k) number is K090598.

When did CARIESCAN PRO receive FDA 510(k) clearance?

CARIESCAN PRO received FDA 510(k) clearance on 2009-12-15, under 510(k) number K090598.

Who is the listed applicant for CARIESCAN PRO?

The FDA 510(k) record lists Cariescan , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARIESCAN PRO?

The FDA product code for CARIESCAN PRO is NBL.

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 Cariescan , Ltd. 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.

K111321REMOTE VIEW SOFTWARE

Related Devices (Code: NBL)

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.

K252464Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd.K242103TRIOS Ready Tip3Shape TRIOS A/SK221275Qraycam PROAIOBIO Co., Ltd.K231722SmarToothSmartooth Co., Ltd.K223470C50SoproK221249L1P-1F (TRIOS 5)3Shape TRIOS A/S

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.

↑