510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K904676Substantially Equivalent

Ndi Model Irs-Td

National Diagnostic Imaging, Inc., Vienna VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904676 is the FDA 510(k) clearance record for NDI MODEL IRS-TD, a class II device, cleared for National Diagnostic Imaging, Inc. on under FDA product code KPR (System, X-Ray, Stationary). FDA records list one 510(k) clearance for National Diagnostic Imaging, Inc. As of , FDA records show no recalls naming K904676.

Clearance record

Decision date
Received
(252 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
National Diagnostic Imaging, Inc. P.O. Box 5501, Vienna VA
Third party review
No

Clearances, product code KPR

Trailing 12 months
7 clearances under product code KPR in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20261
October 20260