Cleared Traditional

DR 800 with Tomosynthesis (K183275) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183275 · Agfa N.V. · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 2019
Decision
70d
Days
Class 2
Risk

K183275 is an FDA 510(k) clearance for the DR 800 with Tomosynthesis. Classified as System, X-ray, Tomographic (product code IZF), Class II - Special Controls.

Submitted by Agfa N.V. (Mortsel, BE). The FDA issued a Cleared decision on February 1, 2019 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1740 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Agfa N.V. devices

Submission Details

510(k) Number K183275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2018
Decision Date February 01, 2019
Days to Decision 70 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 107d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZF System, X-ray, Tomographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Agfa US Corp.
ShaeAnn Cavanagh

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IZF System, X-ray, Tomographic

All 12
Devices cleared under the same product code (IZF) and FDA review panel - the closest regulatory comparables to K183275.
Ortho Device, ADAPTIX 3D Orthopedic Imaging System
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CLISIS SYSTEMS, Discovery RF180
K213081 · General Medical Merate S.P.A · Oct 2021
DR 600 with Tomosynthesis
K193262 · Agfa N.V. · Mar 2020
TOMO-LINK
K944967 · GE Medical Systems · Dec 1994
CLINIX-R TOMOGRAPHIC DEVICE
K810274 · Philips Medical Systems (Cleveland), Inc. · Mar 1981
VTX (GE CATAOLG NO. B7005A)
K792067 · General Electric Co. · Dec 1979