Cleared Traditional

K000987 - VFSS IMAGER, MODEL SIS-300

K000987 is an FDA 510(k) clearance for VFSS IMAGER, manufactured by Lifecare Imaging Intl., Ltd.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K000987 · Lifecare Imaging Intl., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
66d
Days
Class 2
Risk

K000987 is an FDA 510(k) clearance for the VFSS IMAGER, MODEL SIS-300. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Lifecare Imaging Intl., Ltd. (Lake In The Hills, US). The FDA issued a Cleared decision on June 1, 2000 after a review of 66 days - a notably fast clearance cycle.

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: 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 Lifecare Imaging Intl., Ltd. devices

FDA 510(k) Submission Details - K000987

510(k) Number K000987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2000
Decision Date June 01, 2000
Days to Decision 66 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 107d · This submission: 66d
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 188
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K000987.
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
K012424 · Shimadzu Corp. · Oct 2001
EXPEDIO 500D R&F X-RAY SYSTEM
K011624 · GE Medical Systems · Jun 2001
X-RAY SYSTEM XR-MX
K004037 · Karl Storz Endoscopy · Feb 2001
MCA-601, C-ARM MOBILE
K993896 · Medison Radiology Systems, Inc. · Mar 2000
XRT 600 R/F, WRF 0600
K992603 · Wuestec Medical, Inc. · Oct 1999
TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
K993038 · Toshiba America Medical Systems, In.C · Oct 1999