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
K812638Substantially Equivalent

Diagnostic Medical Computer

Diagnostic Resources, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812638 is the FDA 510(k) clearance record for DIAGNOSTIC MEDICAL COMPUTER, a class II device, cleared for Diagnostic Resources, Inc. on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list 4 510(k) clearances for Diagnostic Resources, Inc., from to . As of , FDA records show no recalls naming K812638.

Clearance record

Decision date
Received
(62 days to decision)
Product code
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation
21 CFR 870.1435
Device class
Class II
Review panel
Cardiovascular
Applicant
Diagnostic Resources, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DXG

Trailing 12 months
1 clearance under product code DXG in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260