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FDA 510(k)

INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM

K-Number: K911115 · 1991-12-17

ApplicantInterson Corp.
Decision Date1991-12-17
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Interson Corp.. It received FDA 510(k) clearance on 1991-12-17 under 510(k) number K911115. 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 INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM?

INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1991-12-17. The listed applicant is Interson Corp.. The 510(k) number is K911115.

When did INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM receive FDA 510(k) clearance?

INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM received FDA 510(k) clearance on 1991-12-17, under 510(k) number K911115.

Who is the listed applicant for INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM?

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

What is the FDA product code for INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM?

The FDA product code for INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM is ITX.

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Other records listing Interson Corp. 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.

K911116INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYSTK911113INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYSTK911117INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYSTK911114INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEMK911464INTERSON DISPOSABLE BIOPSY NEEDLEK900555INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.

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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.

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.

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