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)

CTS SYSTEM

K-Number: K941004 · 1994-07-29

ApplicantAcoma Medical Imaging, Inc.
Decision Date1994-07-29
Product CodeIYB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CTS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acoma Medical Imaging, Inc.. It received FDA 510(k) clearance on 1994-07-29 under 510(k) number K941004. The device is classified under product code IYB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CTS SYSTEM?

CTS SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-29. The listed applicant is Acoma Medical Imaging, Inc.. The 510(k) number is K941004.

When did CTS SYSTEM receive FDA 510(k) clearance?

CTS SYSTEM received FDA 510(k) clearance on 1994-07-29, under 510(k) number K941004.

Who is the listed applicant for CTS SYSTEM?

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

What is the FDA product code for CTS SYSTEM?

The FDA product code for CTS SYSTEM is IYB.

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 Acoma Medical Imaging, 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.

K981227SYMPHONY 360 REMOTE CONTROL TABLEK981131PATHFINDER MOBILE C ARMK963851TILTING RADIOGRAPHIC TABLE (REMOTE)K944952ANGIOGRAPHIC SYSTEMK941017F/C/W TUBESTANDK925598BUCKYMATIC AUTOMATIC CHEST FILM CHANGER

View all 13 devices →

Related Devices (Code: IYB)

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.

K935123SUPERSTAND 300Wuestec Medical, Inc.K946261MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000Scott Imaging Intl., Inc.K941017F/C/W TUBESTANDAcoma Medical Imaging, Inc.K940442MPR-814Xri, Inc.K935004MODEL ALPHA TS-2Dpa Consulting, Inc.K933253SUPERSTAND 3000Wuestec 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.

↑