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FDA 510(k)

RADIOMED SOURCE

K-Number: K001070 · 2000-10-24

ApplicantRadiomed Corp.
Decision Date2000-10-24
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOMED SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Radiomed Corp.. It received FDA 510(k) clearance on 2000-10-24 under 510(k) number K001070. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOMED SOURCE?

RADIOMED SOURCE is a medical device that received FDA 510(k) clearance on 2000-10-24. The listed applicant is Radiomed Corp.. The 510(k) number is K001070.

When did RADIOMED SOURCE receive FDA 510(k) clearance?

RADIOMED SOURCE received FDA 510(k) clearance on 2000-10-24, under 510(k) number K001070.

Who is the listed applicant for RADIOMED SOURCE?

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

What is the FDA product code for RADIOMED SOURCE?

The FDA product code for RADIOMED SOURCE is KXK.

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Other records listing Radiomed Corp. 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.

K031206RADIOMED SOFT TISSUE MARKER

Related Devices (Code: KXK)

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

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

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