FDA 510(k)

ARS-1000

K-Number: K820448 · 1982-03-31

Decision Date1982-03-31

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ARS-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Applied Radiation. It received FDA 510(k) clearance on 1982-03-31 under 510(k) number K820448. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARS-1000?

ARS-1000 is a medical device that received FDA 510(k) clearance on 1982-03-31. The listed applicant is Applied Radiation. The 510(k) number is K820448.

When did ARS-1000 receive FDA 510(k) clearance?

ARS-1000 received FDA 510(k) clearance on 1982-03-31, under 510(k) number K820448.

Who is the listed applicant for ARS-1000?

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

What is the FDA product code for ARS-1000?

The FDA product code for ARS-1000 is IYE.

Other records listing Applied Radiation 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.

K827175ARS-1000 RADIATION THERAPY TREATMENT PLANNING SYSTEM

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.