@ Target
FDA 510(k) K983410 · Brainlab AG
510(k) numberK983410
Submission
- Device name
- @ Target
- Applicant
- Brainlab AG
Palo Alto, CA, US - Received
- September 28, 1998
- Decision date
- September 17, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code HAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
More from Claronav
| 510(k) | Device | Decision |
|---|---|---|
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceIYE · Special | 01/14/2026SE |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…LLZ · Special | 10/16/2025SE |
| K252562 | Spine & Trauma Navigation InstrumentsOLO · Special | 09/12/2025SE |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PADOWB · Traditional | 07/22/2025SE |
| K243142 | Cranial 4Pi ImmobilizationIYE · Traditional | 06/23/2025SE |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS…MUJ · Traditional | 06/17/2025SE |
| K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…QIH · Traditional | 06/13/2025SE |
| K243810 | TraumaCad Neo (1.1)QIH · Traditional | 06/04/2025SE |
| K242569 | Mixed Reality Spine NavigationSBF · Traditional | 05/16/2025SE |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…HAW · Traditional | 01/28/2025SE |
Questions and answers
When was @ Target cleared by the FDA?
@ Target (K983410) received a 510(k) decision of Substantially Equivalent on September 17, 1999, 354 days after the submission was received.
What is the product code of K983410?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.