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FDA 510(k)

PACSCAN PLUS, MODELS 300P AND 300AP

K-Number: K092637 · 2009-09-24

ApplicantSonomed, Inc.
Decision Date2009-09-24
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PACSCAN PLUS, MODELS 300P AND 300AP is the device name listed in this FDA 510(k) record. The listed applicant is Sonomed, Inc.. It received FDA 510(k) clearance on 2009-09-24 under 510(k) number K092637. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACSCAN PLUS, MODELS 300P AND 300AP?

PACSCAN PLUS, MODELS 300P AND 300AP is a medical device that received FDA 510(k) clearance on 2009-09-24. The listed applicant is Sonomed, Inc.. The 510(k) number is K092637.

When did PACSCAN PLUS, MODELS 300P AND 300AP receive FDA 510(k) clearance?

PACSCAN PLUS, MODELS 300P AND 300AP received FDA 510(k) clearance on 2009-09-24, under 510(k) number K092637.

Who is the listed applicant for PACSCAN PLUS, MODELS 300P AND 300AP?

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

What is the FDA product code for PACSCAN PLUS, MODELS 300P AND 300AP?

The FDA product code for PACSCAN PLUS, MODELS 300P AND 300AP is ITX.

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Other records listing Sonomed, Inc. 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.

K171098AXIS Image Management SystemK100252MASTER-VU A-SCAN, MV4500K073196MASTER-VUK060626VUMAXK040668E-Z SCAN AB5500+K924311SONOMED 4000P ULTRASONIC PACHYMETER

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Related Devices (Code: ITX)

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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