FDA 510(k)

CT BIOPSYVIEW

K-Number: K983140 · 1998-11-04

ApplicantPhilips Medical Systems North America, Inc.

Decision Date1998-11-04

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CT BIOPSYVIEW is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 1998-11-04 under 510(k) number K983140. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT BIOPSYVIEW?

CT BIOPSYVIEW is a medical device that received FDA 510(k) clearance on 1998-11-04. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K983140.

When did CT BIOPSYVIEW receive FDA 510(k) clearance?

CT BIOPSYVIEW received FDA 510(k) clearance on 1998-11-04, under 510(k) number K983140.

Who is the listed applicant for CT BIOPSYVIEW?

The FDA 510(k) record lists Philips Medical Systems North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT BIOPSYVIEW?

The FDA product code for CT BIOPSYVIEW is JAK.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Philips Medical Systems North America, Inc. as applicant

K102005ALLURA XPER OR TABLE SERIES K062233HEARTSTART MRX MONITOR/DEFIBRILLATOR K062283THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS K061052THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 K050151MULTIDIAGNOST ELEVA K042867PHILIPS ORTHOPAEDIC APPLICATIONS

View all 71 devices →

Related Devices (Code: JAK)

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm Corporation K253836FCT iStream Phase 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770CardIQ SuiteGE Medical Systems SCS K253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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.