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FDA 510(k)

IMAGE

K-Number: K944161 · 1994-12-21

ApplicantAuthorized Hearing Systems, Inc.
Decision Date1994-12-21
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IMAGE is the device name listed in this FDA 510(k) record. The listed applicant is Authorized Hearing Systems, Inc.. It received FDA 510(k) clearance on 1994-12-21 under 510(k) number K944161. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE?

IMAGE is a medical device that received FDA 510(k) clearance on 1994-12-21. The listed applicant is Authorized Hearing Systems, Inc.. The 510(k) number is K944161.

When did IMAGE receive FDA 510(k) clearance?

IMAGE received FDA 510(k) clearance on 1994-12-21, under 510(k) number K944161.

Who is the listed applicant for IMAGE?

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

What is the FDA product code for IMAGE?

The FDA product code for IMAGE is ESD.

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Related PubMed Literature

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.

PMID: 34478784Foundational Considerations for Artificial Intelligence Using Ophthalmic Images.Ophthalmology ()PMID: 33967246Clinical Implementation of Second-generation Minimally Invasive Image-guided Cochlear Implantation Surgery.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology ()PMID: 33505986Evolution and Stagnation of Image Guidance for Surgery in the Lateral Skull: A Systematic Review 1989-2020.Frontiers in surgery ()PMID: 33371797Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology.Toxicologic pathology ()

Other records listing Authorized Hearing 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.

K971693RIONET HB-79PK970057AHS OMEGA SPK963878AHS OMEGA HFK963877AHS OMEGA CONCEPTK963875AHS OMEGA K-AMPK963873AHS OMEGA DEQ

View all 31 devices →

Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, 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.

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