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FDA 510(k)

TOMTECP90

K-Number: K950279 · 1995-09-15

ApplicantTomtec Imaging Systems, Inc.
Decision Date1995-09-15
Product CodeLMB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOMTECP90 is the device name listed in this FDA 510(k) record. The listed applicant is Tomtec Imaging Systems, Inc.. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K950279. The device is classified under product code LMB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMTECP90?

TOMTECP90 is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Tomtec Imaging Systems, Inc.. The 510(k) number is K950279.

When did TOMTECP90 receive FDA 510(k) clearance?

TOMTECP90 received FDA 510(k) clearance on 1995-09-15, under 510(k) number K950279.

Who is the listed applicant for TOMTECP90?

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

What is the FDA product code for TOMTECP90?

The FDA product code for TOMTECP90 is LMB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tomtec Imaging Systems, 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.

K963807TOMTEC ECHO-SCAN

Related Devices (Code: LMB)

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.

K992131SAMSUNG RAYPAX LONG TERM ARCHIVESamsung Sds Co., Ltd.K984405ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp.K983447WISE (II) IMAGE MANAGEMENT SYSTEMSectra-Imtec ABK980243PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)Parameter Developments, Inc.K973463OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVEO Tech, Inc.K973413ID. STORE (RELEASE 2.0)I.S.G. Technologies, 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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