510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K900586Substantially Equivalent

Medrad Fluorovision Hr 2000, High Resolution Image

Medrad, Inc., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900586 is the FDA 510(k) clearance record for MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE, a class II device, cleared for Medrad, Inc. on under FDA product code LLZ (System, Image Processing, Radiological). FDA records list 177 510(k) clearances for Medrad, Inc., from to . As of , FDA records show no recalls naming K900586.

Clearance record

Decision date
Received
(16 days to decision)
Product code
LLZ System, Image Processing, Radiological
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Medrad, Inc. 271 Kappa Dr., Pittsburgh PA
Third party review
No

Clearances, product code LLZ

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