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FDA 510(k)

ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A

K-Number: K991766 · 1999-08-10

ApplicantToshiba America Medical Systems, In.C
Decision Date1999-08-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A 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 1999-08-10 under 510(k) number K991766. 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 ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A?

ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A is a medical device that received FDA 510(k) clearance on 1999-08-10. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K991766.

When did ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A receive FDA 510(k) clearance?

ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A received FDA 510(k) clearance on 1999-08-10, under 510(k) number K991766.

Who is the listed applicant for ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A?

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 ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A?

The FDA product code for ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A is 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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