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FDA 510(k)

TC+ SYSTEM (TILTING C-ARM SYSTEM)

K-Number: K936180 · 1994-03-16

ApplicantGE Medical Systems
Decision Date1994-03-16
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TC+ SYSTEM (TILTING C-ARM SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1994-03-16 under 510(k) number K936180. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TC+ SYSTEM (TILTING C-ARM SYSTEM)?

TC+ SYSTEM (TILTING C-ARM SYSTEM) is a medical device that received FDA 510(k) clearance on 1994-03-16. The listed applicant is GE Medical Systems. The 510(k) number is K936180.

When did TC+ SYSTEM (TILTING C-ARM SYSTEM) receive FDA 510(k) clearance?

TC+ SYSTEM (TILTING C-ARM SYSTEM) received FDA 510(k) clearance on 1994-03-16, under 510(k) number K936180.

Who is the listed applicant for TC+ SYSTEM (TILTING C-ARM SYSTEM)?

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

What is the FDA product code for TC+ SYSTEM (TILTING C-ARM SYSTEM)?

The FDA product code for TC+ SYSTEM (TILTING C-ARM SYSTEM) is OWB.

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Other records listing GE Medical Systems as applicant

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Related Devices (Code: OWB)

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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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