Cleared Traditional

K921986 - PATIENT INFORMATION MANAGER (PIM)

K921986 is an FDA 510(k) clearance for PATIENT INFORMATION MANAGER (PIM), manufactured by Continental X-Ray Corp.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K921986 · Continental X-Ray Corp. · Radiology device
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Oct 1992
Decision
171d
Days
Class 2
Risk

K921986 is an FDA 510(k) clearance for the PATIENT INFORMATION MANAGER (PIM). Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Continental X-Ray Corp. (Broadview, US). The FDA issued a Cleared decision on October 16, 1992 after a review of 171 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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. Standard predicate reliance. 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 Continental X-Ray Corp. devices

FDA 510(k) Submission Details - K921986

510(k) Number K921986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1992
Decision Date October 16, 1992
Days to Decision 171 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 107d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZH Device Classification - Class 2, Special Controls

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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 - IZH System, X-ray, Mammographic

All 45
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K921986.
ADVANCED AUTOMATIC KV
K934831 · Elscint, Inc. · Aug 1994
CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
K933754 · Cook, Inc. · Sep 1993
AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS
K930282 · Elscint, Inc. · Aug 1993
MOBILE ATHENA HF
K922454 · Fischer Imaging Corp. · Sep 1992
MAMMOSCAN
K923061 · Fischer Imaging Corp. · Sep 1992
TILTING MAG
K921896 · Continental X-Ray Corp. · Aug 1992