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FDA 510(k)

DIGITAL RADIATION DETECTOR

K-Number: K771301 · 1977-08-04

ApplicantActus, Inc.
Decision Date1977-08-04
Product CodeIZD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL RADIATION DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Actus, Inc.. It received FDA 510(k) clearance on 1977-08-04 under 510(k) number K771301. The device is classified under product code IZD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL RADIATION DETECTOR?

DIGITAL RADIATION DETECTOR is a medical device that received FDA 510(k) clearance on 1977-08-04. The listed applicant is Actus, Inc.. The 510(k) number is K771301.

When did DIGITAL RADIATION DETECTOR receive FDA 510(k) clearance?

DIGITAL RADIATION DETECTOR received FDA 510(k) clearance on 1977-08-04, under 510(k) number K771301.

Who is the listed applicant for DIGITAL RADIATION DETECTOR?

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

What is the FDA product code for DIGITAL RADIATION DETECTOR?

The FDA product code for DIGITAL RADIATION DETECTOR is IZD.

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.

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Other records listing Actus, 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.

K771614AUTO. WELL TYPE GAMMA COUNTERSK771613WELL TYPE GAMMA COUNTERK771612WELL TYPE GAMMA COUNTER

Related Devices (Code: IZD)

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.

K123917DECLIPSESPECT VIEWERSurgiceye GmbHK101887CONFIDENT SURGERY SUITE 300, MODEL CSS300Surgiceye GmbHK013751HANDHELD GAMMA FINDER (HGF)Silicon Instruments GmhbK983768MODIFICATION TO GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.K982442C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)Care Wise Medical Products Corp.K971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESNeoprobe Corp.

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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