510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944585Substantially Equivalent

Scanning Director

Prentke Romich Co., Wooster OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944585 is the FDA 510(k) clearance record for SCANNING DIRECTOR, a class II device, cleared for Prentke Romich Co. on under FDA product code IQA (System, Environmental Control, Powered). FDA records list 9 510(k) clearances for Prentke Romich Co., from to . As of , FDA records show no recalls naming K944585.

Clearance record

Decision date
Received
(155 days to decision)
Product code
IQA System, Environmental Control, Powered
Regulation
21 CFR 890.3725
Device class
Class II
Review panel
Physical Medicine
Applicant
Prentke Romich Co. 1022 Heyl Rd., Wooster OH
510(k) summary
Statement
Third party review
No

Clearances, product code IQA

Trailing 12 months

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

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