DORO QR3 XTom Headholder System
FDA 510(k) K191979 · Pro Med Instruments GmbH
510(k) numberK191979
Submission
- Device name
- DORO QR3 XTom Headholder System
- Applicant
- Pro Med Instruments GmbH
Freiburg, DE - Received
- July 24, 2019
- Decision date
- October 22, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HBL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250423 | mb-FIX Cranial Stabilization SystemsHBL · Traditional | Medical Bees GmbH | 11/06/2025SE |
| K241883 | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO…HBL · Special | Pro Med Instruments GmbH | 07/26/2024SE |
| K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)HBL · Traditional | Pro Med Instruments GmbH | 04/24/2024SE |
| K203505 | DORO QR3 Headrest System (Aluminum)HBL · Traditional | Pro Med Instruments GmbH | 03/29/2021SE |
| K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull…HBL · Traditional | Pro Med Instruments GmbH | 06/02/2020SE |
| K191740 | DORO LUCENT® iXI and iMRI Headrest SystemHBL · Traditional | Pro Med Instruments GmbH | 02/21/2020SE |
| K191701 | Arcus Head Fixation FrameHBL · Traditional | Mri Interventions, Inc. | 11/15/2019SE |
| K163322 | TZ SKULL PIN AdultHBL · Traditional | Tz Medical, Inc. | 02/23/2017SE |
| K142238 | MAYFIELD Skull ClampHBL · Traditional | Integra LifeSciences Corporation | 11/24/2014SE |
| K141950 | HFD100 Rocker Arm AccessoryHBL · Special | Imris, Inc. | 09/04/2014SE |
More from Imris, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241883 | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO…HBL · Special | 07/26/2024SE |
| K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)HBL · Traditional | 04/24/2024SE |
| K203505 | DORO QR3 Headrest System (Aluminum)HBL · Traditional | 03/29/2021SE |
| K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull…HBL · Traditional | 06/02/2020SE |
| K191740 | DORO LUCENT® iXI and iMRI Headrest SystemHBL · Traditional | 02/21/2020SE |
| K063494 | Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsHBL · Traditional | 05/21/2007SE |
| K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables…GEI · Traditional | 05/16/2007SE |
| K032331 | Doro Radiolucent Headrest System and Horseshoe Headrests,And Non-Radiolucent J-Arm…HBL · Traditional | 11/20/2003SE |
| K001808 | Doro Headrest SystemHBL · Traditional | 08/04/2000SE |
Questions and answers
When was DORO QR3 XTom Headholder System cleared by the FDA?
DORO QR3 XTom Headholder System (K191979) received a 510(k) decision of Substantially Equivalent on October 22, 2019, 90 days after the submission was received.
What is the product code of K191979?
The FDA product code is HBL – Holder, Head, Neurosurgical (Skull Clamp), a Class II (moderate risk) device regulated under 21 CFR 882.4460.