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)

VIOLA II DENTAL CAMERA SYSTEM

K-Number: K973035 · 1997-09-24

ApplicantInnovative Medical Systems, Inc.
Decision Date1997-09-24
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VIOLA II DENTAL CAMERA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-09-24 under 510(k) number K973035. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIOLA II DENTAL CAMERA SYSTEM?

VIOLA II DENTAL CAMERA SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-24. The listed applicant is Innovative Medical Systems, Inc.. The 510(k) number is K973035.

When did VIOLA II DENTAL CAMERA SYSTEM receive FDA 510(k) clearance?

VIOLA II DENTAL CAMERA SYSTEM received FDA 510(k) clearance on 1997-09-24, under 510(k) number K973035.

Who is the listed applicant for VIOLA II DENTAL CAMERA SYSTEM?

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

What is the FDA product code for VIOLA II DENTAL CAMERA SYSTEM?

The FDA product code for VIOLA II DENTAL CAMERA SYSTEM is EIA.

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 Innovative 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.

K951469BAZOOKA SYSTEMK933184POSITIVE AIRWAY PRESSURE SYSTEMK924590MICROWAVE AUTOMATED TISSUE PROCESSORK922081LABOTECH AUTOMATED MICROTITER ANALYZERK921005AUTOLOADERK915457PHACO 20/20 SYSTEM I

View all 22 devices →

Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, 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.

↑