510(k) K171257

Device: ClearPoint System
Applicant: MRI Interventions, Inc.
510(k) number: K171257
Product code: ORR
Decision: Substantially Equivalent (SESE)
Decision date: 2017-10-20
Date received: 2017-04-28
Regulation: 882.4560
Classification name: Neurological Stereotaxic Instrument, Real-time Intraoperative Mri
Medical specialty: Neurology
Review panel: Neurology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Pete Piferi
Address: 5 Musick Irvine CA US 92618 92618

FDA Registration Numbers#

2029275
2011171

Source Documents#

Other 510(k) Records For Product Code ORR #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K181195	ClearPoint System	Mri Interventions, Inc.	2018-11-02
K111073	SURGIVISION INC. CLEARPOINT SYSTEM	Surgi-Vision, Inc.	2011-06-22
K100836	CLEARPOINT SYSTEM	Surgivision, Inc.	2010-06-16

Legacy Summary#

summary

FDA Review#

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