Universal 1417PI— 510(k) K252996
Substantially EquivalentKonica Minolta Healthcare Americas, Inc.
FDA 510(k) clearance K252996 for Universal 1417PI, Substantially Equivalent on 2026-06-12. Applicant: Konica Minolta Healthcare Americas, Inc.. Device class: 2.
Summary
Konica Minolta Healthcare Americas' Universal 1417PI is filed under MQB, solid state x-ray imagers (flat panel or digital imagers). The record doesn't describe it beyond the model name and the code name.
Class II, 21 CFR 892.1680. Radiology is both the classification panel and the review panel, and the submission was an Abbreviated 510(k).
Konica Minolta filed from Garner, North Carolina. Review took 267 calendar days (September 18, 2025 to June 12, 2026).
Clearance details
- Applicant
- Konica Minolta Healthcare Americas, Inc.
- Product code
- Product code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Garner, NC, US
Recent devices under product code MQB
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