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FDA 510(k)

COMPUTERIZED RADIATION TREATMENT PLANNING SYS

K-Number: K853964 · 1985-12-05

ApplicantComputerized Medical Systems, Inc.
Decision Date1985-12-05
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPUTERIZED RADIATION TREATMENT PLANNING SYS is the device name listed in this FDA 510(k) record. The listed applicant is Computerized Medical Systems, Inc.. It received FDA 510(k) clearance on 1985-12-05 under 510(k) number K853964. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUTERIZED RADIATION TREATMENT PLANNING SYS?

COMPUTERIZED RADIATION TREATMENT PLANNING SYS is a medical device that received FDA 510(k) clearance on 1985-12-05. The listed applicant is Computerized Medical Systems, Inc.. The 510(k) number is K853964.

When did COMPUTERIZED RADIATION TREATMENT PLANNING SYS receive FDA 510(k) clearance?

COMPUTERIZED RADIATION TREATMENT PLANNING SYS received FDA 510(k) clearance on 1985-12-05, under 510(k) number K853964.

Who is the listed applicant for COMPUTERIZED RADIATION TREATMENT PLANNING SYS?

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

What is the FDA product code for COMPUTERIZED RADIATION TREATMENT PLANNING SYS?

The FDA product code for COMPUTERIZED RADIATION TREATMENT PLANNING SYS is LHN.

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Other records listing Computerized Medical Systems, Inc. as applicant

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Related Devices (Code: LHN)

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.

K260597VIRTUE QAProNova SolutionsK260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, 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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