Cleared Traditional

InterView XP (K221984) - FDA 510(k) Clearance

Also marketed or referenced as:
InterView FUSION

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

K221984 · Mediso Medical Imaging Systems, Lttd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
266d
Days
Class 2
Risk

K221984 is an FDA 510(k) clearance for the InterView XP. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Mediso Medical Imaging Systems, Lttd. (Budapest, HU). The FDA issued a Cleared decision on March 29, 2023 after a review of 266 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Mediso Medical Imaging Systems, Lttd. devices

Submission Details

510(k) Number K221984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2022
Decision Date March 29, 2023
Days to Decision 266 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
159d slower than avg
Panel avg: 107d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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

Cro Group, Inc.
William McLain

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 - LLZ System, Image Processing, Radiological

All 812
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K221984.
Limbus Contour
K230575 · Limbus Ai, Inc. · Apr 2023
CereFlow™ V1.2
K211059 · Translational Mri, LLC · Mar 2023
RadAlly
K213660 · Imaging Wave, LLC · Mar 2023
FlightPlan for Embolization
K223490 · GE Medical Systems SCS · Mar 2023
Syngo Carbon Space VA30A
K230561 · Siemens Healthcare GmbH · Mar 2023
CoverScan (CoverScan v1.1)
K230294 · Perspectum · Mar 2023