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FDA 510(k)

DIGITAL IMAGING SYSTEM

K-Number: K954159 · 1996-03-19

ApplicantCamtronics, Ltd.
Decision Date1996-03-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Camtronics, Ltd.. It received FDA 510(k) clearance on 1996-03-19 under 510(k) number K954159. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL IMAGING SYSTEM?

DIGITAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-19. The listed applicant is Camtronics, Ltd.. The 510(k) number is K954159.

When did DIGITAL IMAGING SYSTEM receive FDA 510(k) clearance?

DIGITAL IMAGING SYSTEM received FDA 510(k) clearance on 1996-03-19, under 510(k) number K954159.

Who is the listed applicant for DIGITAL IMAGING SYSTEM?

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

What is the FDA product code for DIGITAL IMAGING SYSTEM?

The FDA product code for DIGITAL IMAGING SYSTEM is LLZ.

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Other records listing Camtronics, Ltd. 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.

K021236SURGERY AND ACCESSORIESK013032PHYSIOLOG, SERIES 95000K992666VIDEO PLUS SYSTEM, SERIES 95000K992259ECHOCARDIOGRAPHY SYSTEM SERIES 95000K990066CCD CAMERA, MODEL 9000K955519ANALYTICAL REVIEW STATION

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Related Devices (Code: LLZ)

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.

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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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