510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950279Substantially Equivalent

Tomtecp90

TOMTEC Imaging Systems GmbH, Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950279 is the FDA 510(k) clearance record for TOMTECP90, a class I device, cleared for Tomtec Imaging Systems, Inc. on under FDA product code LMB (Device, Digital Image Storage, Radiological). FDA's definition for product code LMB reads: "Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images". FDA records list 23 510(k) clearances for Tomtec Imaging Systems, Inc., from to . As of , FDA records show no recalls naming K950279.

Clearance record

Decision date
Received
(234 days to decision)
Product code
LMB Device, Digital Image Storage, Radiological
Regulation
21 CFR 892.2010
Device class
Class I
Review panel
Radiology
Applicant
Tomtec Imaging Systems, Inc. 4775 Walnut St., Suite C, Boulder CO
510(k) summary
Summary
Third party review
No

Clearances, product code LMB

Trailing 12 months

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

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