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FDA 510(k)

RADIOSURGERY VERIFICATION PHANTOM

K-Number: K954634 · 1995-12-22

ApplicantThe Phantom Laboratory, Inc.
Decision Date1995-12-22
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOSURGERY VERIFICATION PHANTOM is the device name listed in this FDA 510(k) record. The listed applicant is The Phantom Laboratory, Inc.. It received FDA 510(k) clearance on 1995-12-22 under 510(k) number K954634. 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 RADIOSURGERY VERIFICATION PHANTOM?

RADIOSURGERY VERIFICATION PHANTOM is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is The Phantom Laboratory, Inc.. The 510(k) number is K954634.

When did RADIOSURGERY VERIFICATION PHANTOM receive FDA 510(k) clearance?

RADIOSURGERY VERIFICATION PHANTOM received FDA 510(k) clearance on 1995-12-22, under 510(k) number K954634.

Who is the listed applicant for RADIOSURGERY VERIFICATION PHANTOM?

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

What is the FDA product code for RADIOSURGERY VERIFICATION PHANTOM?

The FDA product code for RADIOSURGERY VERIFICATION PHANTOM is IYE.

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 The Phantom Laboratory, 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.

K082909RSVP HALF SPHERE PHANTOM, MODEL DDP010K081760RSVP PHANTOM PELVIS, MODEL TLP260K002840MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM

Related Devices (Code: IYE)

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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