Cleared Traditional

K970908 - HOWTEK 960

K970908 is an FDA 510(k) clearance for HOWTEK 960, manufactured by Howtek, Inc.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K970908 · Howtek, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
70d
Days
Class 2
Risk

K970908 is an FDA 510(k) clearance for the HOWTEK 960. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Howtek, Inc. (Hudson, US). The FDA issued a Cleared decision on May 20, 1997 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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.

FDA 510(k) Submission Details - K970908

510(k) Number K970908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1997
Decision Date May 20, 1997
Days to Decision 70 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
37d faster than avg
Panel avg: 107d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMA Device Classification - Class 2, Special Controls

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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 - LMA Digitizer, Image, Radiological

All 56
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K970908.
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
K974619 · Afp Imaging Corp. · Feb 1998
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
K973411 · General Scanning, Inc. · Dec 1997
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
K971894 · Eastman Kodak Company · Aug 1997
CALL-RAD PC TELERADIOLOGY
K964288 · Pc Teleradiology · Apr 1997
FILM SCANNER 300
K960839 · Cannon U.S.A., Inc. · Dec 1996
KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)
K961768 · Kodak Health Imaging Systems, Inc. · Aug 1996
K970908 · HOWTEK 960
Download PDF FDA Summary Howtek, Inc.