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Toshiba Medical Systems · Predicate Candidate Screening

54 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

83 daysmedian FDA review time

203 days90th percentile

54clearances measured

K-number	Device	Applicant	Decided	Review days
K960948	SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A	Toshiba Medical Systems	1996-12-23	290
K954310	BLA-800A	Toshiba Medical Systems	1995-10-18	33
K954309	ANGIOREX	Toshiba Medical Systems	1995-10-06	21
K893750	MRT-50A MOBILE	Toshiba Medical Systems	1989-08-09	83
K891453	DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V	Toshiba Medical Systems	1989-06-01	78
K890969	TRANSESOPHAGEAL TRANSDUCER PEF-511SA	Toshiba Medical Systems	1989-05-16	78
K884788	TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM	Toshiba Medical Systems	1989-02-27	104
K884555	TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM	Toshiba Medical Systems	1989-02-27	119
K883359	DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A	Toshiba Medical Systems	1989-01-25	168
K883756	TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM	Toshiba Medical Systems	1988-11-14	69
K881305	TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM	Toshiba Medical Systems	1988-10-19	205
K881013	MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A	Toshiba Medical Systems	1988-08-29	172
K882959	ENDOVAGINAL PROBE, SMS-510VA	Toshiba Medical Systems	1988-08-18	35
K875266	SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM	Toshiba Medical Systems	1988-04-29	129
K872288	SONOLAYER-V, SAL-38B	Toshiba Medical Systems	1988-01-11	209
K863269	SONOLAYER - V, SSA-100A.	Toshiba Medical Systems	1987-07-22	331
K871175	JUMBO DIGITAL GAMMACAMERA, GCA-901A	Toshiba Medical Systems	1987-03-31	7
K863364	DIAGNOSTIC ULTRASONIC TRANSDUCER	Toshiba Medical Systems	1987-02-27	178
K863577	DOPPLER UNIT, SDS-100A	Toshiba Medical Systems	1987-02-25	166
K863947	SONOLAYER-L, SAL-77B	Toshiba Medical Systems	1987-01-09	91
K863935	TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY	Toshiba Medical Systems	1986-12-02	54
K860531	SONOLAYER-L, SAL-38A, WITH SCANNER SAL-38AS	Toshiba Medical Systems	1986-07-18	156
K860281	CONVEX PROBE, PVE-382M	Toshiba Medical Systems	1986-05-27	119
K853115	SONOLAYER S, SSH-60A/SDS-60A	Toshiba Medical Systems	1986-03-12	231
K855124	CONVEX PROBE, PVE-382M	Toshiba Medical Systems	1986-03-12	79
K853739	SONOLAYER SAL-55A/55AS	Toshiba Medical Systems	1986-02-24	171
K854606	SONOLAYER S, SSH-65A	Toshiba Medical Systems	1986-02-20	94
K852090	SONOLAYER-L, SAL-77A	Toshiba Medical Systems	1985-12-02	203
K852159	NEW OPTIONAL PROBES FOR SSA-90A	Toshiba Medical Systems	1985-12-02	199
K853470	JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2	Toshiba Medical Systems	1985-11-19	92
K853311	LINEAR ARRAY PROBE PLB-310M FOR SAL-32B	Toshiba Medical Systems	1985-11-13	98
K853444	TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS	Toshiba Medical Systems	1985-11-08	84
K851240	SONOLAYER-L SAL-32B	Toshiba Medical Systems	1985-09-23	180
K851526	CONVEX PROBE, PVE-393M	Toshiba Medical Systems	1985-09-23	161
K851036	SONOLAYER-V, SSA-90A	Toshiba Medical Systems	1985-09-17	188
K852903	TOSHIBA DIGITAL CLINICAL THERMOMTER	Toshiba Medical Systems	1985-07-24	15
K851685	DIGITAL GAMMA CAMERA GCA 601 E	Toshiba Medical Systems	1985-06-14	52
K851687	JUMBO DIGITAL GAMMACAMERA GCA-90B	Toshiba Medical Systems	1985-06-05	43
K851686	DIGITAL GAMMA CAMERA GCA 501S	Toshiba Medical Systems	1985-06-05	43
K844037	DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DIGIFORMER	Toshiba Medical Systems	1985-03-01	136
K844124	TOSHIBA DIGITAL CLINICAL THERMOMETER	Toshiba Medical Systems	1984-12-07	45
K781739	CAMERA, GCA-10A, LOW ENERGY	Toshiba Medical Systems	1978-11-27	41
K771600	ULTRASOUND	Toshiba Medical Systems	1977-09-22	34
K771599	GAMMA CAMERAS -GXA-301 & GCA-402	Toshiba Medical Systems	1977-09-20	32
K771601	X-RAY REMOTE CONTROL TABLE	Toshiba Medical Systems	1977-09-20	32
K771292	HIGH-SPEED SECTOR SCANNING SSL-52H	Toshiba Medical Systems	1977-08-16	68
K771291	IMAGE SCANNING TYPE SONOLAY. SAL-10A	Toshiba Medical Systems	1977-08-16	68
K771296	TUBE CONVEYOR MODEL DS-PB-4	Toshiba Medical Systems	1977-08-03	55
K771298	6 L.L. SYSTEM	Toshiba Medical Systems	1977-08-03	55
K771295	X-RAY GENERATOR MODEL KX0-825	Toshiba Medical Systems	1977-08-03	55

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda