LungMaps
FDA 510(k) clearance K253690 · decided 2026-06-15
Clearance details
- K-number
- K253690
- Device name
- LungMaps
- Applicant
- Siemens Healthineers AG
- Decision
- Substantially Equivalent
- Date received
- 2025-11-21
- Decision date
- 2026-06-15
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- QIH
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Forchheim, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Siemens Healthineers AG
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| mdprostate (K252571) | Mediaire GmbH | 2026-08-07 |
| RealGUIDE (K253902) | 3DIEMME SRL | 2026-08-04 |
| Affinity (K253835) | Hermes Medical Solutions AB | 2026-07-31 |
| cmAngio® V2.0 (K260980) | Curemetrix, Inc. | 2026-07-30 |
| Cleerly Plaque (K261210) | Cleerly, Inc. | 2026-07-29 |
| DIANA (K260192) | ROPCA ApS | 2026-07-24 |
| SwiftMR (K261349) | Airs Medical, Inc. | 2026-07-24 |
| VELMENI for DENTISTS (V4D) 3D (K254096) | Velmeni, Inc. | 2026-07-23 |
| Hi-D Imaging 4TAVR (K261535) | Hi-D Imaging AG | 2026-07-20 |
| SkeletonPlanner (K260206) | UPlanner B.V. - Presurgeo | 2026-07-15 |
| InferOperate Suite (K260973) | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026-07-07 |
| Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) (K253628) | Agada Medical, Ltd. | 2026-06-29 |
Recalls involving this device
No recalls on record reference this clearance.