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FDA 510(k)

SONOLAYER S, SSH-65A

K-Number: K854606 · 1986-02-20

ApplicantToshiba Medical Systems
Decision Date1986-02-20
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SONOLAYER S, SSH-65A is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems. It received FDA 510(k) clearance on 1986-02-20 under 510(k) number K854606. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOLAYER S, SSH-65A?

SONOLAYER S, SSH-65A is a medical device that received FDA 510(k) clearance on 1986-02-20. The listed applicant is Toshiba Medical Systems. The 510(k) number is K854606.

When did SONOLAYER S, SSH-65A receive FDA 510(k) clearance?

SONOLAYER S, SSH-65A received FDA 510(k) clearance on 1986-02-20, under 510(k) number K854606.

Who is the listed applicant for SONOLAYER S, SSH-65A?

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

What is the FDA product code for SONOLAYER S, SSH-65A?

The FDA product code for SONOLAYER S, SSH-65A is DXK.

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Other records listing Toshiba Medical Systems 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.

K960948SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020AK954310BLA-800AK954309ANGIOREXK893750MRT-50A MOBILEK891453DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582VK890969TRANSESOPHAGEAL TRANSDUCER PEF-511SA

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Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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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