510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K870071Substantially Equivalent

Toshiba, Smit Roentgen

North American Imaging, Inc., Monument CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870071 is the FDA 510(k) clearance record for TOSHIBA, SMIT ROENTGEN, a class I device, cleared for North American Imaging, Inc. on under FDA product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic). FDA records list one 510(k) clearance for North American Imaging, Inc. As of , FDA records show no recalls naming K870071.

Clearance record

Decision date
Received
(13 days to decision)
Product code
ITY Assembly, Tube Housing, X-Ray, Diagnostic
Regulation
21 CFR 892.1760
Device class
Class I
Review panel
Radiology
Applicant
North American Imaging, Inc. P.O. Box 1629, Monument CO
Third party review
No

Clearances, product code ITY

Trailing 12 months

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

FDA records show no clearances under product code ITY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ITY, 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