510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001341Substantially Equivalent

Dr5000 Dedicated Chest X-Ray System

Analogic Corp., Peabody MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001341 is the FDA 510(k) clearance record for DR5000 DEDICATED CHEST X-RAY SYSTEM, a class II device, cleared for Analogic Corp. on under FDA product code KPR (System, X-Ray, Stationary). FDA records list 39 510(k) clearances for Analogic Corp., from to . As of , FDA records show 2 recalls naming K001341.

Clearance record

Decision date
Received
(36 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Analogic Corp. 8 Centennial Dr., Peabody MA
510(k) summary
Statement
Third party review
No

Clearances, product code KPR

Trailing 12 months
7 clearances under product code KPR in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20261
October 20260