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
13465–13488 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 12, 1989
DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A
K892386 · IYO
Toshiba America Medical Systems, In.C
Radiology · 158d
Cleared Sep 12, 1989
5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER
K894054 · IYN
Advanced Technology Laboratories, Inc.
Radiology · 97d
Cleared Sep 12, 1989
PHASE 2 TRANSCRANIAL PROBE
K894163 · IYN
Biosound, Inc.
Radiology · 90d
Cleared Sep 12, 1989
30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE
K894479 · IZO
Bennett X-Ray Corp.
Radiology · 56d
Cleared Sep 12, 1989
MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM
K894974 · LNH
Resonex, Inc.
Radiology · 36d
Cleared Sep 11, 1989
AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER
K893833 · IYN
Acoustic Imaging
Radiology · 108d
Cleared Sep 07, 1989
ACCESS TM
K894290 · LNH
Diasonics, Inc.
Radiology · 76d
Cleared Sep 07, 1989
ELSCINT'S EXEL 2400E CT SCANNER
K894542 · JAK
Elscint, Inc.
Radiology · 49d
Cleared Sep 07, 1989
FABFOAM #302
K894683 · JAD
Jewell Industries
Radiology · 44d
Cleared Sep 06, 1989
SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT
K890913 · IYO
Shimadzu Precision Instruments, Inc.
Radiology · 194d
Cleared Sep 01, 1989
MEDISYS RECORD AND VERIFY SYSTEM
K893978 · IYE
Medisys, Inc.
Radiology · 91d
Cleared Sep 01, 1989
MOBILE X-RAY UNIT
K894021 · IZL
Ziehm International, Inc.
Radiology · 87d
Cleared Sep 01, 1989
CT HILIGHT ADVANTAGE
K894269 · JAK
GE Medical Systems
Radiology · 71d
Cleared Aug 28, 1989
TOMAX ULTRASCAN
K892653 · IZF
Incubation Industries, Inc.
Radiology · 137d
Cleared Aug 28, 1989
VERICORD S3
K894123 · IYE
Philips Medical Systems, Inc.
Radiology · 77d
Cleared Aug 28, 1989
PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735)
K894230 · IYE
Siemens Medical Laboratories, Inc.
Radiology · 70d
Cleared Aug 23, 1989
PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER
K892358 · KPS
Adac Laboratories
Radiology · 139d
Cleared Aug 22, 1989
CVIS ULTRA-SCAN ONE IMAGING CATHETER
K893837 · IYO
Cardiovascular Imaging Systems, Inc.
Radiology · 90d
Cleared Aug 17, 1989
CENTRALITE BACKPOINTER
K893398 · IWE
Diacor, Inc.
Radiology · 108d
Cleared Aug 11, 1989
XENOS MOBILECAM
K893379 · IYX
Xenos Medical Systems, Inc.
Radiology · 102d
Cleared Aug 11, 1989
GE SIGNA ADVANTAGE
K893509 · LNH
GE Medical Systems
Radiology · 98d
Cleared Aug 10, 1989
VARIAN MULTILEAF COLLIMATOR
K893464 · IXI
Varian Assoc., Inc.
Radiology · 99d
Cleared Aug 10, 1989
UROVIEW II
K893475 · JAA
Oec-Diasonics, Inc.
Radiology · 98d
Cleared Aug 09, 1989
UNICATH A
K892849 · IZI
Xre Corp.
Radiology · 113d