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FDA 510(k)

MODIFICATION TO GAMMA GUIDANCE SYSTEM

K-Number: K983768 · 1999-07-02

ApplicantRadiation Monitoring Devices, Inc.
Decision Date1999-07-02
Product CodeIZD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO GAMMA GUIDANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radiation Monitoring Devices, Inc.. It received FDA 510(k) clearance on 1999-07-02 under 510(k) number K983768. 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 MODIFICATION TO GAMMA GUIDANCE SYSTEM?

MODIFICATION TO GAMMA GUIDANCE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-07-02. The listed applicant is Radiation Monitoring Devices, Inc.. The 510(k) number is K983768.

When did MODIFICATION TO GAMMA GUIDANCE SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO GAMMA GUIDANCE SYSTEM received FDA 510(k) clearance on 1999-07-02, under 510(k) number K983768.

Who is the listed applicant for MODIFICATION TO GAMMA GUIDANCE SYSTEM?

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

What is the FDA product code for MODIFICATION TO GAMMA GUIDANCE SYSTEM?

The FDA product code for MODIFICATION TO GAMMA GUIDANCE SYSTEM 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 Radiation Monitoring Devices, 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.

K961321GAMMA GUIDANCE SYSTEM

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 GmhbK982442C-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.K961321GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, 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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