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)

DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM

K-Number: K080004 · 2008-01-23

ApplicantSicel Technologies, Inc.
Decision Date2008-01-23
Product CodeNZT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sicel Technologies, Inc.. It received FDA 510(k) clearance on 2008-01-23 under 510(k) number K080004. The device is classified under product code NZT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM?

DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 2008-01-23. The listed applicant is Sicel Technologies, Inc.. The 510(k) number is K080004.

When did DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM receive FDA 510(k) clearance?

DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM received FDA 510(k) clearance on 2008-01-23, under 510(k) number K080004.

Who is the listed applicant for DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM?

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

What is the FDA product code for DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM?

The FDA product code for DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM is NZT.

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 Sicel Technologies, Inc. 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.

K083035DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEMK081859MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEMK071399DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100K061051DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETERK052118DOSE VERIFICATION SYSTEMK040687ONEDOSE PATIENT DOSIMETRY SYSTEM

View all 7 devices →

Related Devices (Code: NZT)

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.

K250083PRO-DOSE SystemNu-Rise, SAK182395OARtrac SystemRadialdyne, LLCK162954OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLCK083035DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEMSicel Technologies, 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.

↑