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

Ultrasound Imaging For Vascular Access For Hemodialysis

21 CFR 892.1560 / Radiology
FDA source (opens on fda.gov)

SGH is the FDA product code for Ultrasound Imaging For Vascular Access For Hemodialysis, a class II device type, regulated under 21 CFR 892.1560. FDA's definition for this code reads: "Ultrasound imaging for vascular access for hemodialysis". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SGH
Device name
Ultrasound Imaging For Vascular Access For Hemodialysis
FDA definition
Ultrasound imaging for vascular access for hemodialysis
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SGH

By decision year
1 clearance under product code SGH with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SGH by decision year
YearClearances
20251

Applicants with the most clearances

Product code SGH
Applicants holding the most 510(k) clearances under product code SGH
ApplicantClearances
X9 Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code