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FDA 510(k)

HEAD-SPINE STABILIZER HSS-1

K-Number: K844549 · 1985-03-01

ApplicantImaging Accessories, Inc.
Decision Date1985-03-01
Product CodeIWY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEAD-SPINE STABILIZER HSS-1 is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Accessories, Inc.. It received FDA 510(k) clearance on 1985-03-01 under 510(k) number K844549. The device is classified under product code IWY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEAD-SPINE STABILIZER HSS-1?

HEAD-SPINE STABILIZER HSS-1 is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Imaging Accessories, Inc.. The 510(k) number is K844549.

When did HEAD-SPINE STABILIZER HSS-1 receive FDA 510(k) clearance?

HEAD-SPINE STABILIZER HSS-1 received FDA 510(k) clearance on 1985-03-01, under 510(k) number K844549.

Who is the listed applicant for HEAD-SPINE STABILIZER HSS-1?

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

What is the FDA product code for HEAD-SPINE STABILIZER HSS-1?

The FDA product code for HEAD-SPINE STABILIZER HSS-1 is IWY.

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 Imaging Accessories, 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.

K844926HEAD-SPINE STABILIZER HSS-1

Related Devices (Code: IWY)

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.

K925705ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEMDenar Corp.K884493HEAD HOLDING DEVICE/SLEEP APNEAX-Ray SystemsK884847MTD HEDRESTComposites Horizons, Inc.K864527DUOCEPHGary E. Hall, DdsK850197KELLER CEPHALOMETRIC DEVICEGary D. KellerK843340PORTA-STATPorta-Stat, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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