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FDA 510(k)

TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L

K-Number: K033604 · 2003-12-15

ApplicantPie Medical
Decision Date2003-12-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical. It received FDA 510(k) clearance on 2003-12-15 under 510(k) number K033604. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L?

TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L is a medical device that received FDA 510(k) clearance on 2003-12-15. The listed applicant is Pie Medical. The 510(k) number is K033604.

When did TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L receive FDA 510(k) clearance?

TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L received FDA 510(k) clearance on 2003-12-15, under 510(k) number K033604.

Who is the listed applicant for TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L?

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

What is the FDA product code for TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L?

The FDA product code for TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L is IYO.

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Other records listing Pie Medical 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.

K061961ART LAB SOFTWAREK053154MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEMK043588MYLAB 15 / MYLAB 20, MODEL 2700K043360IMT.LABK041675PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMSK023512PICUS ULTRASOUND IMAGING SYSTEMS

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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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