Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PSF-50ET

K-Number: K910850 · 1992-01-29

ApplicantToshiba America Medical Systems, In.C
Decision Date1992-01-29
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PSF-50ET 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 1992-01-29 under 510(k) number K910850. 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 PSF-50ET?

PSF-50ET is a medical device that received FDA 510(k) clearance on 1992-01-29. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K910850.

When did PSF-50ET receive FDA 510(k) clearance?

PSF-50ET received FDA 510(k) clearance on 1992-01-29, under 510(k) number K910850.

Who is the listed applicant for PSF-50ET?

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 PSF-50ET?

The FDA product code for PSF-50ET is ITX.

Other records listing Toshiba America Medical Systems, In.C 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.

K132106INFINIX ANGIO WORKSTATION W/DTS SOFTWAREK131822ULTRAEXTEND USWS-900A V2.1 AND V3.1K123097DOSE TRACKING SYSTEM MODEL XIDF-DTS801K122613VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/USK121076ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGEK122842RADREX-I, SW V4.00 MODEL DRAD-3000E

View all 143 devices →

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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.

↑