510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812893Substantially Equivalent

Superflab

Mick Radio-Nuclear Instruments, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812893 is the FDA 510(k) clearance record for SUPERFLAB, a class I device, cleared for Mick Radio-Nuclear Instruments, Inc. on under FDA product code IYP (Phantom, Anthropomorphic, Nuclear). FDA records list 43 510(k) clearances for Mick Radio-Nuclear Instruments, Inc., from to . As of , FDA records show no recalls naming K812893.

Clearance record

Decision date
Received
(54 days to decision)
Product code
IYP Phantom, Anthropomorphic, Nuclear
Regulation
21 CFR 892.1370
Device class
Class I
Review panel
Radiology
Applicant
Mick Radio-Nuclear Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
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