Cleared Traditional

MOBIL XR (K781705) - FDA 510(k) Clearance

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

K781705 · Siemens Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1978
Decision
14d
Days
Class 2
Risk

K781705 is an FDA 510(k) clearance for the MOBIL XR. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Siemens Corp. (Mchenry, US). The FDA issued a Cleared decision on October 24, 1978 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Siemens Corp. devices

Submission Details

510(k) Number K781705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1978
Decision Date October 24, 1978
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 Peers - IZL System, X-ray, Mobile

All 95
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K781705.
MX MOBILE X-RAY SYSTEM
K862452 · Philips Medical Systems (Cleveland), Inc. · Jul 1986
APR MOBILE
K843192 · Philips Medical Systems (Cleveland), Inc. · Sep 1984
AMX-III
K802047 · General Electric Co. · Oct 1980
CAP-MOBILE
K781425 · Philips Medical Systems (Cleveland), Inc. · Sep 1978
HITACHI TECH-MOBLE DHC-121
K780313 · Philips Medical Systems (Cleveland), Inc. · Mar 1978
MOBILE X-RAY SYS. MODEL 43820A
K771571 · Hewlett-Packard Co. · Aug 1977