# K191740: DORO LUCENT® iXI and iMRI Headrest System

- Pathway: 510(k) (Traditional)
- Applicant: Pro Med Instruments GmbH
- Decided: Feb 21, 2020 after 235 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K944964 (1995). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 50 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063494: Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components, Pro-Med Instruments GmbH (2007) Summary page 5.

## Most influential descendants
- K240319: DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) (2024), 0 descendants of its own

## Indications for use
The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used. The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used. The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.

Source page: https://510kreport.com/device/K191740
Methodology: https://510kreport.com/methodology