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FDA 510(k)

REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A

K-Number: K950972 · 1996-04-15

ApplicantToshiba America Medical Systems, In.C
Decision Date1996-04-15
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 1996-04-15 under 510(k) number K950972. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A?

REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K950972.

When did REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A receive FDA 510(k) clearance?

REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A received FDA 510(k) clearance on 1996-04-15, under 510(k) number K950972.

Who is the listed applicant for REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A?

The FDA product code for REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A is JAK.

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Related Devices (Code: JAK)

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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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