Photonova Spectra, Photonova Spectra Select— 510(k) K253520
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K253520 for Photonova Spectra, Photonova Spectra Select, Substantially Equivalent on 2026-03-20. Applicant: Ge Medical Systems, LLC. Device class: 2.
Summary
Ge Medical Systems' record covers Photonova Spectra and Photonova Spectra Select, filed under JAK, computed tomography x-ray systems. The record doesn't describe either one beyond its name and that code name.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Ge Medical Systems filed from Waukesha, Wisconsin. Review took 128 calendar days (November 12, 2025 to March 20, 2026).
Clearance details
- Applicant
- Ge Medical Systems, LLC
- Product code
- Product code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code JAK
view allMore clearances from Ge Medical Systems, LLC
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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.