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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 a medical device manufactured by Pro Med Instruments GmbH. It received FDA 510(k) clearance on 2020-02-21 under approval 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. It is manufactured by Pro Med Instruments GmbH. The 510(k) number is K191740.

When was DORO LUCENT® iXI and iMRI Headrest System approved by the FDA?

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

What company makes DORO LUCENT® iXI and iMRI Headrest System?

DORO LUCENT® iXI and iMRI Headrest System is manufactured by Pro Med Instruments GmbH.

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 Devices by Pro Med Instruments GmbH

K191979DORO QR3 XTom Headholder System K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) K203505DORO QR3 Headrest System (Aluminum) 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)

Related Devices (Code: HBL)

K163322TZ SKULL PIN AdultTz Medical, Inc. K191701Arcus Head Fixation FrameMri Interventions, Inc. K191979DORO QR3 XTom Headholder SystemPro Med Instruments GmbH K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)Pro Med Instruments GmbH K203505DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbH 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)Pro Med Instruments GmbH

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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