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)

AUTIMO 2.5-D AND AUTIMO 3-D

K-Number: K972016 · 1997-12-04

ApplicantC.L. Mcintosh & Assoc., Inc.
Decision Date1997-12-04
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AUTIMO 2.5-D AND AUTIMO 3-D is the device name listed in this FDA 510(k) record. The listed applicant is C.L. Mcintosh & Assoc., Inc.. It received FDA 510(k) clearance on 1997-12-04 under 510(k) number K972016. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTIMO 2.5-D AND AUTIMO 3-D?

AUTIMO 2.5-D AND AUTIMO 3-D is a medical device that received FDA 510(k) clearance on 1997-12-04. The listed applicant is C.L. Mcintosh & Assoc., Inc.. The 510(k) number is K972016.

When did AUTIMO 2.5-D AND AUTIMO 3-D receive FDA 510(k) clearance?

AUTIMO 2.5-D AND AUTIMO 3-D received FDA 510(k) clearance on 1997-12-04, under 510(k) number K972016.

Who is the listed applicant for AUTIMO 2.5-D AND AUTIMO 3-D?

The FDA 510(k) record lists C.L. Mcintosh & Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTIMO 2.5-D AND AUTIMO 3-D?

The FDA product code for AUTIMO 2.5-D AND AUTIMO 3-D is IXI.

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 C.L. Mcintosh & Assoc., 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.

K970131ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICEK961725OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISIONK942227NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM

Related Devices (Code: IXI)

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.

K253025Ricoh 3D for Healthcare BolusRicoh 3D For Healthcare, LLCK222639VHA Radiotherapy BolusVha DeanK214093VSP Bolus3D SystemsK132236.DECIMAL PROTON APERTURE.Decimal, Inc.K131150CURA COMPENSATORCura Medical Technologies, LLCK123893CURA COLLIMATORCura Medical Technologies, 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.

↑