510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945708Substantially Equivalent

Sii 360 Ms

Scott Imaging Intl., Inc., Mobile AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945708 is the FDA 510(k) clearance record for SII 360 MS, a class II device, cleared for Scott Imaging Intl., Inc. on under FDA product code KPR (System, X-Ray, Stationary). FDA records list 7 510(k) clearances for Scott Imaging Intl., Inc., from to . As of , FDA records show no recalls naming K945708.

Clearance record

Decision date
Received
(23 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Scott Imaging Intl., Inc. 3510 Cottage Hill Rd., Mobile AL
510(k) summary
Statement
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