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)

SIREMOBIL ISO-C 3D

K-Number: K040347 · 2004-03-09

ApplicantSiemens Medical Systems, Inc.
Decision Date2004-03-09
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIREMOBIL ISO-C 3D is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-03-09 under 510(k) number K040347. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIREMOBIL ISO-C 3D?

SIREMOBIL ISO-C 3D is a medical device that received FDA 510(k) clearance on 2004-03-09. The listed applicant is Siemens Medical Systems, Inc.. The 510(k) number is K040347.

When did SIREMOBIL ISO-C 3D receive FDA 510(k) clearance?

SIREMOBIL ISO-C 3D received FDA 510(k) clearance on 2004-03-09, under 510(k) number K040347.

Who is the listed applicant for SIREMOBIL ISO-C 3D?

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

What is the FDA product code for SIREMOBIL ISO-C 3D?

The FDA product code for SIREMOBIL ISO-C 3D is OXO.

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 Siemens Medical Systems, 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.

K123540SYNGO CT PULMO 3DK123541SYNGO.CT NEURO PERFUSIONK122909SYNGO SINGLE SOURCE DUAL ENGERYK122471SOMATOM DEFINITIONK120579SOMATOM DEFINITION EDGEK121072SOMATOM DEFINITION FLASH

View all 23 devices →

Related Devices (Code: OXO)

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.

K253296Digital C-ARM with 3DAllengers Medical Systems LimitedK252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, 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.

↑