510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K001012Substantially Equivalent

Digital Integration System, Dis2000

Wellington Medical Systems, Inc., Dartmouth MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001012 is the FDA 510(k) clearance record for DIGITAL INTEGRATION SYSTEM, DIS2000, a class II device, cleared for Wellington Medical Systems, Inc. on under FDA product code LLZ (System, Image Processing, Radiological). FDA records list one 510(k) clearance for Wellington Medical Systems, Inc. As of , FDA records show no recalls naming K001012.

Clearance record

Decision date
Received
(76 days to decision)
Product code
LLZ System, Image Processing, Radiological
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Wellington Medical Systems, Inc. 19 Harvest Ave., Dartmouth MA
510(k) summary
Statement
Third party review
No

Clearances, product code LLZ

Trailing 12 months
48 clearances under product code LLZ in the twelve months to October 2026, July 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code LLZ, trailing twelve months
MonthClearances
November 20254
December 20251
January 20263
February 20264
March 20266
April 20262
May 20265
June 20265
July 20268
August 20263
September 20267
October 20260