# K063494: Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components

- Pathway: 510(k) (Traditional)
- Applicant: Pro-Med Instruments GmbH
- Decided: May 21, 2007 after 182 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: 8 generations back to K944964 (1995). 47 ancestors in all.
7 later devices descend from it; 4 cite it directly.
1 of 55 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032331: Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm Retractor System (Aluminum Alloy), Pro-Med Instruments GmbH (2003) Summary page 2.
- K001808: Doro Headrest System, Pro-Med Instruments GmbH (2000) Summary page 2.
- K051501: Zirace, Acucera, Inc. (2005) Summary page 2.
- K953124: Mayfield Radiolucent 2000 Skull Clamp, Ohio Medical Instrument Co., Inc. (1996) Summary page 5.

## Most influential descendants
- K072208: Mayfield Disposable and Reusable Titanium Skull Pins (2007), 4 descendants of its own
- K103493: Head Fiation Device (HFD 100) (2011), 2 descendants of its own
- K191740: DORO LUCENT® iXI and iMRI Headrest System (2020), 1 descendant of its own
- K250423: mb-FIX Cranial Stabilization Systems (2025), 0 descendants of its own
- 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 Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins The DORO® Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins are components of a mechanical support system which is used in head and neck surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative CT or MR Imaging is used. The Radiolucent / MRI Compatible Horseshoe Headrest System The DORO® Radiolucent / MRI Compatible Horseshoe Headrest System are components of a mechanical support system which is used in head and neck surgery when non-invasive head support is required and when intra-operative CT or MR Imaging is used. The Radiolucent / MRI Compatible Halo System The DORO® Radiolucent / MRI Compatible Halo System is a system of radiolucent halo rings of varying size and styles that may be used in neurosurgical applications as an arm rest during head and neck surgery when intra-operative CT or MR Imaging is required.

Source page: https://510kreport.com/device/K063494
Methodology: https://510kreport.com/methodology