Surgical Navigation Advanced Platform (SNAP)
510(k) K160584
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160584 | Date28 Jun 2016 | StatusActive |
Official records
- FDA 510(k) database K160584
Recalls
-
- Terminated Z-0322-2026
- Terminated Z-0320-2026
- Terminated Z-0321-2026
- Terminated Z-0323-2026
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Timeline
- Cleared FDA 510(k) K160584
- Recall initiated FDA recalls Z-0322-2026
- Recall initiated FDA recalls Z-0320-2026
- Recall initiated FDA recalls Z-0321-2026
- Recall initiated FDA recalls Z-0323-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Surgical Theater, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Surgical Navigation Advanced Platform (SNAP) is a software interface and image segmentation system used to transfer imaging information from medical scanners such as CT, MR or X-ray 3D Angiography (XA) to an output file. It is also used for simulating surgical treatment options pre-operatively and post-operatively.
The SNAP system features a compact and sturdy design with a slim cart suitable for operating rooms and an iPad for displaying the main screen image, allowing for full control capabilities and remote use. It is supplied with an iPad and is intended for use in operating rooms. The device has been cleared by the FDA with a 510(k) clearance (K160584).
Devices cleared under K160584
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Endo SNAP | Endo SNAP | 00863157000329 | — | On the market |
| SNAP Desktop VR SNAP | VR SNAP | 00863157000312 | — | On the market |
| SNAP Mini Desktop VR MSNAP | VR MSNAP | 00863157000367 | — | On the market |
| SNAP OR | SNAP | 00863157000305 | — | On the market |
| SNAP Patient Engagement PE SNAP | PE SNAP | 00863157000374 | — | On the market |
| SyncAR SNAP | SyncAR | 00860003884102 | — | On the market |
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