# K191979: DORO QR3 XTom Headholder System

- Pathway: 510(k) (Traditional)
- Applicant: Pro Med Instruments GmbH
- Decided: Oct 22, 2019 after 90 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: 2 generations back to K913233 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 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 5.

## Indications for use
The DORO® QR3 XTom Headholder System is 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 with a CT-Scanner is used.

Source page: https://510kreport.com/device/K191979
Methodology: https://510kreport.com/methodology