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FDA 510(k)

ENTERSCAN

K-Number: K874081 · 1987-12-31

ApplicantPie Data Medical BV
Decision Date1987-12-31
Product CodeLWI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ENTERSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Pie Data Medical BV. It received FDA 510(k) clearance on 1987-12-31 under 510(k) number K874081. The device is classified under product code LWI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERSCAN?

ENTERSCAN is a medical device that received FDA 510(k) clearance on 1987-12-31. The listed applicant is Pie Data Medical BV. The 510(k) number is K874081.

When did ENTERSCAN receive FDA 510(k) clearance?

ENTERSCAN received FDA 510(k) clearance on 1987-12-31, under 510(k) number K874081.

Who is the listed applicant for ENTERSCAN?

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

What is the FDA product code for ENTERSCAN?

The FDA product code for ENTERSCAN is LWI.

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 Pie Data Medical BV 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.

K874192MULTIPURPOSE TRANSDUCER RANGEK870653ULTRASOUND LINEAR/SECTOR SCANNER 1100K870058PIE MEDICAL SCANNER 1000K871082FETAL CARE MONITOR ANTEPARTUM 1500

Related Devices (Code: LWI)

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.

K960421SINUSCAN 102/SINUSPRINTFerguson MedicalK960044ULTRAMAX/MODEL NUMBER A1Entlab OYK960241CPR GENERAL SURGERY TRAYCustom Pack Reliability

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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