510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921878Substantially Equivalent

Scanmate III

Circadian, Inc., San Leandro CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921878 is the FDA 510(k) clearance record for SCANMATE III, a class I device, cleared for Circadian, Inc. on under FDA product code IYP (Phantom, Anthropomorphic, Nuclear). FDA records list 13 510(k) clearances for Circadian, Inc., from to . As of , FDA records show no recalls naming K921878.

Clearance record

Decision date
Received
(144 days to decision)
Product code
IYP Phantom, Anthropomorphic, Nuclear
Regulation
21 CFR 892.1370
Device class
Class I
Review panel
Radiology
Applicant
Circadian, Inc. 16303 Panoramic Way, San Leandro CA
510(k) summary
Summary
Third party review
No

Clearances, product code IYP

Trailing 12 months

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

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