Cleared Traditional

K914525 - FLUROSPOT H VERSION 2

K914525 is the FDA 510(k) clearance for FLUROSPOT H VERSION 2 by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code JAA) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K914525 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
40d
Days
Class 2
Risk

K914525 is an FDA 510(k) clearance for the FLUROSPOT H VERSION 2. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on November 19, 1991 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K914525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1991
Decision Date November 19, 1991
Days to Decision 40 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
67d faster than avg
Panel avg: 107d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 132
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K914525.
DIGITAL RADIOGRAPHY SYSTEM IDR-2000
K920721 · Shimadzu Medical Systems · Apr 1992
PEGASUS LATERAL CARDIAC POSITIONER
K915592 · Fischer Imaging Corp. · Jan 1992
FVP-1000 FAMILY AND FVP-1000D FAMILY
K905694 · Fischer Imaging Corp. · Nov 1991
PHILIPS DIAGNOST 96
K912470 · Philips Medical Systems, Inc. · Aug 1991
LASER BEAM LOCALIZER FOR SIREMOBIL 4
K912380 · Siemens Medical Solutions USA, Inc. · Jul 1991
PHILIPS INTEGRIS I 2000 SYSTEM
K904012 · Philips Medical Systems, Inc. · Nov 1990