Cleared Traditional

K151007 - 21.3 inch (54 cm) Color Digital Mammogr...

K151007 is an FDA 510(k) clearance for 21.3 inch (54 cm) Color Digital Mammogr..., manufactured by Jvckenwood Corporation. The device is a Class 2 Radiology device with product code PGY cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K151007 · Jvckenwood Corporation · Radiology device
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May 2015
Decision
23d
Days
Class 2
Risk

K151007 is an FDA 510(k) clearance for the 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550). Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Jvckenwood Corporation (Yokohama, JP). The FDA issued a Cleared decision on May 8, 2015 after a review of 23 days - a notably fast clearance 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: 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 Jvckenwood Corporation devices

FDA 510(k) Submission Details - K151007

510(k) Number K151007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2015
Decision Date May 08, 2015
Days to Decision 23 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
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGY Device Classification - Class 2, Special Controls

Product Code PGY Display, Diagnostic Radiology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.
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 - PGY Display, Diagnostic Radiology

All 111
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K151007.
Coronis Uniti
K151505 · Barco N.V. · Jul 2015
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K151238 · Nanjing Jusha Display Technology Co., Ltd. · Jun 2015
21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
K151134 · Jvckenwood Corporation · May 2015
JUSHA-M53 Medical Display
K150842 · Nanjing Jusha Display Technology Co., Ltd. · Apr 2015
JUSHA-M52C Medical Display
K150746 · Nanjing Jusha Display Technology Co., Ltd. · Apr 2015
2MP Color LCD Monitor, RadiForce RS240
K150106 · Eizo Corporation · Apr 2015