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FDA 510(k)

100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS

K-Number: K002357 · 2000-11-09

ApplicantPie Medical
Decision Date2000-11-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical. It received FDA 510(k) clearance on 2000-11-09 under 510(k) number K002357. 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 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS?

100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS is a medical device that received FDA 510(k) clearance on 2000-11-09. The listed applicant is Pie Medical. The 510(k) number is K002357.

When did 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS receive FDA 510(k) clearance?

100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS received FDA 510(k) clearance on 2000-11-09, under 510(k) number K002357.

Who is the listed applicant for 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS?

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 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS?

The FDA product code for 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS 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 SYSTEMSK033604TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L

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Related Devices (Code: IYO)

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.

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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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