FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
11521–11544 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 20, 1995
MRT-50 QD BODY COIL
K945875 · LNH
Toshiba America Mri, Inc.
Radiology · 140d
Cleared Apr 20, 1995
KOORDINAT M
K951176 · IXR
Siemens Medical Solutions USA, Inc.
Radiology · 36d
Cleared Apr 19, 1995
UPSCAN
K933512 · KPR
Merlin Engineering Works, Inc.
Radiology · 638d
Cleared Apr 19, 1995
TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY
K950532 · EAP
Trophy Radiologie
Radiology · 71d
Cleared Apr 12, 1995
ECHO PLANAR IMAGING I
K945828 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 134d
Cleared Apr 12, 1995
HYPERPACS PACS AND TELERAFIOLOGY SYSTEM
K950343 · LMD
Rogan Imaging Corp.
Radiology · 75d
Cleared Apr 11, 1995
X-RAY FILM PROCESSOR
K940112 · IXW
Fischer Industries, Inc.
Radiology · 456d
Cleared Apr 11, 1995
MOBIL C-ARM, REGURBISHED, VARIOUS MODELS
K950971 · JAA
Pro-Tronics, Inc.
Radiology · 49d
Cleared Apr 10, 1995
ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER)
K940772 · LNH
Fonar Corp.
Radiology · 412d
Cleared Apr 10, 1995
OLYMPUS ULTRASONIC PROBES
K944610 · ITX
Olympus America, Inc.
Radiology · 203d
Cleared Apr 10, 1995
2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
K951004 · KPY
Kenex , Ltd.
Radiology · 54d
Cleared Apr 07, 1995
PENN-PET SCANNER
K945721 · KPS
Ugm Medical Systems, Inc.
Radiology · 137d
Cleared Apr 06, 1995
FLEXART(TM) QD C-SPINE COIL
K945665 · LNH
Toshiba America Mri, Inc.
Radiology · 140d
Cleared Apr 06, 1995
MRT-35A UPGRADE 8.0CD
K945798 · LNH
Toshiba America Mri, Inc.
Radiology · 129d
Cleared Apr 06, 1995
CARBON FIBER COUCH INSERT
K950068 · KXJ
Medtec, Inc.
Radiology · 87d
Cleared Apr 06, 1995
AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER
K950667 · EAP
Chicago X-Ray Systems, Inc.
Radiology · 52d
Cleared Apr 06, 1995
ANGIOREX CAT-350B
K951053 · IZZ
Toshiba America Medical Systems, In.C
Radiology · 30d
Cleared Apr 04, 1995
AUTOLASER MULTI FORMAT CAMERA
K950288 · LMC
Afp Imaging Corp.
Radiology · 69d
Cleared Apr 03, 1995
BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY
K945962 · IZH
Bennett X-Ray Corp.
Radiology · 117d
Cleared Apr 03, 1995
POLYDOROS SX 65 AND 80
K950883 · IZO
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Apr 03, 1995
ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650
K950981 · IXR
Biodex Medical Systems, Inc.
Radiology · 31d
Cleared Apr 03, 1995
KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)
K951003 · KPY
Kenex , Ltd.
Radiology · 47d
Cleared Apr 03, 1995
KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)
K951006 · IXA
Kenex , Ltd.
Radiology · 47d
Cleared Mar 31, 1995
MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM
K941353 · IZH
Elscint, Inc.
Radiology · 375d