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FDA 510(k)

OLDELFT THORASCAN MODEL NUMBER 180T

K-Number: K012165 · 2001-09-19

ApplicantNucletron Corp.
Decision Date2001-09-19
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OLDELFT THORASCAN MODEL NUMBER 180T is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corp.. It received FDA 510(k) clearance on 2001-09-19 under 510(k) number K012165. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLDELFT THORASCAN MODEL NUMBER 180T?

OLDELFT THORASCAN MODEL NUMBER 180T is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Nucletron Corp.. The 510(k) number is K012165.

When did OLDELFT THORASCAN MODEL NUMBER 180T receive FDA 510(k) clearance?

OLDELFT THORASCAN MODEL NUMBER 180T received FDA 510(k) clearance on 2001-09-19, under 510(k) number K012165.

Who is the listed applicant for OLDELFT THORASCAN MODEL NUMBER 180T?

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

What is the FDA product code for OLDELFT THORASCAN MODEL NUMBER 180T?

The FDA product code for OLDELFT THORASCAN MODEL NUMBER 180T is KPR.

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Other records listing Nucletron Corp. as applicant

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Related Devices (Code: KPR)

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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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