FDA Product Code LDK: Device, Sensing, Optical Contour
Leading manufacturers include Cryos Technologies, Inc., Nsite, Inc. and Momentum Health, Inc..
8
Total
8
Cleared
184d
Avg days
1980
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Device, Sensing, Optical Contour Devices (Product Code LDK)
8 devices
Cleared
Nov 15, 2023
NSite Scoliosis Assessment App
Nsite, Inc.
Physical Medicine
267d
Cleared
Oct 04, 2023
Momentum Spine
Momentum Health, Inc.
Physical Medicine
89d
Cleared
Aug 28, 2019
CryoVizion System
Cryos Technologies, Inc.
Physical Medicine
254d
Cleared
Mar 21, 1985
ISIS
Oxford Medilog, Inc.
Physical Medicine
106d
Cleared
Apr 02, 1980
CONTOUROGRAPH M-500
Bio-Tek Instruments, Inc.
Physical Medicine
16d
About Product Code LDK - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code LDK since 1980, with 8 receiving FDA clearance (average review time: 184 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.