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
13825–13848 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 10, 1988
MAMEX DC MG11
K881505 · IZH
Orion Corp.
Radiology · 60d
Cleared Jun 10, 1988
MAMEX DC MAG MG12
K881506 · IZH
Orion Corp.
Radiology · 60d
Cleared Jun 08, 1988
EXTENDED MULTIPURPOSE TRANSDUCER RANGE
K880580 · IYO
Pie Medical USA BV
Radiology · 119d
Cleared Jun 06, 1988
DPX BONE DENSITOMETER
K873296 · KGI
Lunar Radiation Corp.
Radiology · 294d
Cleared Jun 06, 1988
ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY
K880982 · KPR
Orion Corporation Soredex
Radiology · 90d
Cleared May 31, 1988
SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE
K882019 · IXR
General Electric Co.
Radiology · 18d
Cleared May 25, 1988
SENOGRAPHE 600T AND 600TS SENIX HF
K881882 · IZH
General Electric Co.
Radiology · 21d
Cleared May 18, 1988
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX
K875370 · JAK
Shimadzu Precision Instruments, Inc.
Radiology · 139d
Cleared May 18, 1988
DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
K881688 · IZJ
Adac Laboratories
Radiology · 29d
Cleared May 16, 1988
PROBE SHEATH FOR ADMS ULTRASOUND PROBE
K881208 · IYO
Advanced Diagnostic Medical Systems,...
Radiology · 56d
Cleared May 11, 1988
ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE
K875251 · IYO
Philips Medical Systems (Cleveland),...
Radiology · 141d
Cleared May 04, 1988
SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650
K880519 · IZO
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650
K880521 · IZO
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80
K880522 · IZO
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75
K880523 · IZO
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100
K880524 · IZO
Fischer Imaging Corp.
Radiology · 85d
Cleared May 02, 1988
ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.
K874363 · IYO
Acuson Computed Sonography
Radiology · 192d
Cleared May 02, 1988
SL SERIES, SL 15, 18, 20 & 25
K874558 · IYE
Philips Medical Systems, Inc.
Radiology · 180d
Cleared May 02, 1988
MAMMOGRAPHIC X-RAY SYSTEM ATHENA
K880531 · IZH
Fischer Imaging Corp.
Radiology · 83d
Cleared Apr 29, 1988
EXL-22DP X-RAY RADIATION THERAPY SYSTEM
K873398 · IYE
Mitsubishi Intl. Corp.
Radiology · 249d
Cleared Apr 27, 1988
7.5 MHZ ENDORECTAL PROBE
K881028 · IYO
Philips Ultrasound, Inc.
Radiology · 48d
Cleared Apr 27, 1988
A2J MZ 45 LASER LIGHT FOR POSITIONING
K881591 · IWX
A2j, Inc.
Radiology · 14d
Cleared Apr 25, 1988
TC2-64B TRANSCRANIAL DOPPLER
K874684 · IYO
Carolina Medical Electronics
Radiology · 165d
Cleared Apr 25, 1988
TRANS-SCAN 3-D TRANSCRANIAL DOPPLER
K874685 · IYO
Carolina Medical Electronics
Radiology · 165d