KONICA MINOLTA, INC.

Address:1 SAKURA-MACHI,HINO-SHI Tokyo,JP

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (10)

Premarket Exempt

No Yes

Clear

REGIUS MODEL SIGMA - 04560141933194 Catalog Number :

Device Class : 2

Duns Number: 692076161

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

REGIUS Cassette - 04560141933200 Catalog Number :

Device Class : 2

Duns Number: 692076161

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

REGIUS Cassette - 04560141933217 Catalog Number :

Device Class : 2

Duns Number: 692076161

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

REGIUS Cassette - 04560141933224 Catalog Number :

Device Class : 2

Duns Number: 692076161

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

REGIUS Cassette - 04560141933231 Catalog Number :

Device Class : 2

Duns Number: 692076161

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

REGIUS Cassette - 04560141933248 Catalog Number :

Device Class : 2

Duns Number: 692076161

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

REGIUS Cassette - 04560141933361 Catalog Number :

Device Class : 2

Duns Number: 692076161

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

AeroDR P-11 - 04560141933613 Catalog Number :

Device Class : 2

Duns Number: 692076161

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

REGIUS Cassette - 04560141933736 Catalog Number :

Device Class : 2

Duns Number: 692076161

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

REGIUS Cassette - 04560141933743 Catalog Number :

Device Class : 2

Duns Number: 692076161

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

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