Cleared Traditional

K905694 - FVP-1000 FAMILY AND FVP-1000D FAMILY

K905694 is an FDA 510(k) clearance for FVP-1000 FAMILY AND FVP-1000D FAMILY, manufactured by Fischer Imaging Corp.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K905694 · Fischer Imaging Corp. · Radiology device
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Nov 1991
Decision
343d
Days
Class 2
Risk

K905694 is an FDA 510(k) clearance for the FVP-1000 FAMILY AND FVP-1000D FAMILY. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on November 27, 1991 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fischer Imaging Corp. devices

FDA 510(k) Submission Details - K905694

510(k) Number K905694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1990
Decision Date November 27, 1991
Days to Decision 343 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
236d slower than avg
Panel avg: 107d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

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 189
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K905694.
DIGITAL RADIOGRAPHY SYSTEM IDR-1000
K920720 · Shimadzu Medical Systems · Apr 1992
DIGITAL RADIOGRAPHY SYSTEM IDR-2000
K920721 · Shimadzu Medical Systems · Apr 1992
PEGASUS LATERAL CARDIAC POSITIONER
K915592 · Fischer Imaging Corp. · Jan 1992
FLUROSPOT H VERSION 2
K914525 · Siemens Medical Solutions USA, Inc. · 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