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FDA 510(k)

IMAGE

K-Number: K781169 · 1978-08-31

ApplicantDeringer-Ney, Inc.
Decision Date1978-08-31
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMAGE is the device name listed in this FDA 510(k) record. The listed applicant is Deringer-Ney, Inc.. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781169. The device is classified under product code EJT. It was reviewed by the DE 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 1978-08-31. The listed applicant is Deringer-Ney, Inc.. The 510(k) number is K781169.

When did IMAGE receive FDA 510(k) clearance?

IMAGE received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781169.

Who is the listed applicant for IMAGE?

The FDA 510(k) record lists Deringer-Ney, 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 EJT.

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Related PubMed Literature

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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 Deringer-Ney, 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.

K933178GDC 3509K930482DENTAL CASTING ALLOY, MODIFICATION - PF-3K930481DENTAL CASTING ALLOY MODIFICATION-PF-4K925273GDC 3445K920922GDC 3367K920060DENTAL SOLDER ALLOY

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Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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