510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K973834Substantially Equivalent

Cs2000 & Cs2000 Tomo

Pausch Corp., Tenton Falls NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973834 is the FDA 510(k) clearance record for CS2000 & CS2000 TOMO, a class II device, cleared for Pausch Corp. on under FDA product code IZF (System, X-Ray, Tomographic). FDA records list 9 510(k) clearances for Pausch Corp., from to . As of , FDA records show no recalls naming K973834.

Clearance record

Decision date
Received
(204 days to decision)
Product code
IZF System, X-Ray, Tomographic
Regulation
21 CFR 892.1740
Device class
Class II
Review panel
Radiology
Applicant
Pausch Corp. 808 Shrewsbury Ave., Tenton Falls NJ
510(k) summary
Statement
Third party review
No

Clearances, product code IZF

Trailing 12 months
2 clearances under product code IZF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260