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FDA 510(k)

DORO LUCENT® iXI and iMRI Headrest System

K-Number: K191740 · 2020-02-21

ApplicantPro Med Instruments GmbH
Decision Date2020-02-21
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DORO LUCENT® iXI and iMRI Headrest System is the device name listed in this FDA 510(k) record. The listed applicant is Pro Med Instruments GmbH. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K191740. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DORO LUCENT® iXI and iMRI Headrest System?

DORO LUCENT® iXI and iMRI Headrest System is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Pro Med Instruments GmbH. The 510(k) number is K191740.

When did DORO LUCENT® iXI and iMRI Headrest System receive FDA 510(k) clearance?

DORO LUCENT® iXI and iMRI Headrest System received FDA 510(k) clearance on 2020-02-21, under 510(k) number K191740.

Who is the listed applicant for DORO LUCENT® iXI and iMRI Headrest System?

The FDA 510(k) record lists Pro Med Instruments GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DORO LUCENT® iXI and iMRI Headrest System?

The FDA product code for DORO LUCENT® iXI and iMRI Headrest System is HBL.

Other records listing Pro Med Instruments GmbH 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.

K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)K203505DORO QR3 Headrest System (Aluminum)K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)K191979DORO QR3 XTom Headholder System

Related Devices (Code: HBL)

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.

K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbHK241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)Pro Med Instruments GmbHK240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbHK203505DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbHK193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)Pro Med Instruments GmbHK191701Arcus Head Fixation FrameMri Interventions, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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