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)

MULTISCAN 7

K-Number: K853852 · 1985-11-19

ApplicantMultiscan, Inc.
Decision Date1985-11-19
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MULTISCAN 7 is the device name listed in this FDA 510(k) record. The listed applicant is Multiscan, Inc.. It received FDA 510(k) clearance on 1985-11-19 under 510(k) number K853852. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTISCAN 7?

MULTISCAN 7 is a medical device that received FDA 510(k) clearance on 1985-11-19. The listed applicant is Multiscan, Inc.. The 510(k) number is K853852.

When did MULTISCAN 7 receive FDA 510(k) clearance?

MULTISCAN 7 received FDA 510(k) clearance on 1985-11-19, under 510(k) number K853852.

Who is the listed applicant for MULTISCAN 7?

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

What is the FDA product code for MULTISCAN 7?

The FDA product code for MULTISCAN 7 is ITX.

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

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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.

↑