510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K971451Substantially Equivalent

Wise Image Management System

O Tech, Inc., Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971451 is the FDA 510(k) clearance record for WISE IMAGE MANAGEMENT SYSTEM, a class I device, cleared for O Tech, Inc. on under FDA product code LMB (Device, Digital Image Storage, Radiological). FDA's definition for product code LMB reads: "Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images". FDA records list 4 510(k) clearances for O Tech, Inc., from to . As of , FDA records show no recalls naming K971451.

Clearance record

Decision date
Received
(66 days to decision)
Product code
LMB Device, Digital Image Storage, Radiological
Regulation
21 CFR 892.2010
Device class
Class I
Review panel
Radiology
Applicant
O Tech, Inc. 6741 Grant Ln., Plano TX
510(k) summary
Summary
Third party review
No

Clearances, product code LMB

Trailing 12 months

FDA records hold no clearances under product code LMB in the trailing twelve months.

FDA records show no clearances under product code LMB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LMB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260