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)

OSCAR 3

K-Number: K093805 · 2010-02-19

ApplicantOrthosonics, Ltd.
Decision Date2010-02-19
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSCAR 3 is the device name listed in this FDA 510(k) record. The listed applicant is Orthosonics, Ltd.. It received FDA 510(k) clearance on 2010-02-19 under 510(k) number K093805. The device is classified under product code JDX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSCAR 3?

OSCAR 3 is a medical device that received FDA 510(k) clearance on 2010-02-19. The listed applicant is Orthosonics, Ltd.. The 510(k) number is K093805.

When did OSCAR 3 receive FDA 510(k) clearance?

OSCAR 3 received FDA 510(k) clearance on 2010-02-19, under 510(k) number K093805.

Who is the listed applicant for OSCAR 3?

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

What is the FDA product code for OSCAR 3?

The FDA product code for OSCAR 3 is JDX.

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 Orthosonics, 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.

K083830OSCAR BONE RESECTORK051053OSCAR, MODEL OE3000DBK021502OSCAR, MODEL OE3000

Related Devices (Code: JDX)

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.

K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research ConsortiumK163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon GroupK153743PIEZOSURGERY PLUSMectron S.P.A.K132848PIEZOSURGERY FLEXMectron S.P.A.K100410PIEZOELECTRIC SYSTEMSatelec

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.

↑