AIR Recon DL— 510(k) K253808
Substantially EquivalentGE Medical Systems
FDA 510(k) clearance K253808 for AIR Recon DL, Substantially Equivalent on 2026-08-13. Applicant: GE Medical Systems. Device class: 2.
Summary
GE Medical Systems filed AIR Recon DL under product code LNH, nuclear magnetic resonance imaging systems. The record doesn't expand the name or describe the product further.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
GE filed from Waukesha, Wisconsin. FDA found it substantially equivalent 258 calendar days after receipt (November 28, 2025 to August 13, 2026).
Clearance details
- Applicant
- GE Medical Systems
- Product code
- Product code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code LNH
view allMore clearances from GE Medical Systems
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.