Cleared Traditional

K913757 - HOLOGIC CER 20/20

K913757 is an FDA 510(k) clearance for HOLOGIC CER 20/20, manufactured by Hologic, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K913757 · Hologic, Inc. · Radiology device
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Oct 1991
Decision
70d
Days
Class 2
Risk

K913757 is an FDA 510(k) clearance for the HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Hologic, Inc. (Waltham, US). The FDA issued a Cleared decision on October 30, 1991 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Hologic, Inc. devices

FDA 510(k) Submission Details - K913757

510(k) Number K913757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1991
Decision Date October 30, 1991
Days to Decision 70 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
37d faster than avg
Panel avg: 107d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 183
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K913757.
DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR
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K921112 · Fujifilm Medical System U.S.A., Inc. · Apr 1993
FLOOR MOUNT TUBESTAND-PERFORMER-N 6610.102/S-9110
K912515 · Continental X-Ray Corp. · Sep 1991
FLOOR MOUNT TUBESTAND PERFORMER, 6610.101/S-9109
K912517 · Continental X-Ray Corp. · Sep 1991
HYDRA VISION UROLOGICAL X-RAY SYSTEM
K904145 · Mallinckrodt Group, Inc. · Dec 1990