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FDA 510(k)

DIGITAL RADIOGRAPHY SYSTEM

K-Number: K810364 · 1981-03-11

ApplicantAdac Laboratories
Decision Date1981-03-11
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL RADIOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Adac Laboratories. It received FDA 510(k) clearance on 1981-03-11 under 510(k) number K810364. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL RADIOGRAPHY SYSTEM?

DIGITAL RADIOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Adac Laboratories. The 510(k) number is K810364.

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

DIGITAL RADIOGRAPHY SYSTEM received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810364.

Who is the listed applicant for DIGITAL RADIOGRAPHY SYSTEM?

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

What is the FDA product code for DIGITAL RADIOGRAPHY SYSTEM?

The FDA product code for DIGITAL RADIOGRAPHY SYSTEM is JAA.

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Other records listing Adac Laboratories 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.

K062298APOLLO GAMMA CAMERA SYSTEMK061029JETSTREAM WORKSPACEK060020AUTOQUANT PLUSK051351PRECEDENCE SPECT/CT IMAGING SYSTEMK042880JETSTREAM WORKSPACEK042903AUTOSPECS

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Related Devices (Code: JAA)

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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