Atlas FDA

DIGORA

FDA 510(k) clearance K934949 · decided 1994-02-10

Clearance details

K-number
K934949
Device name
DIGORA
Applicant
Orion Corporation Soredex
Decision
Substantially Equivalent
Date received
1993-10-18
Decision date
1994-02-10
Days to decision
115 days
Clearance type
Traditional
Product code
IXK
Device class
2
Regulation number
892.1630
Medical specialty
Radiology
Advisory committee
Radiology
Location
Helsinki, FI
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Orion Corporation Soredex

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA (K093640)Electron Jsco.2011-04-29
PVMED DDR 2520 DIGITAL IMAGING SYSTEM (K072766)Portavision Medical2007-12-11
RADIOTHERAPY SOLUTION BASED ON CR (K042779)Agfa Corp.2004-10-21
PORT CASSETTE (K032654)Orex Computed Radiography, Ltd.2003-10-09
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (K003689)Canon USA, Inc.2002-01-02
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO (K000159)Agfa Corp.2000-02-16
FUJI FCR IMAGE PROCESSING UNIT IP-U515 (K942561)Fujifilm Medical System U.S.A., Inc.1994-12-23
FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS (K931002)Fujifilm Medical System U.S.A., Inc.1993-06-08
DIGISCAN 2 (K924459)Siemens Medical Solutions USA, Inc.1992-12-17
FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE (K923990)Fujifilm Medical System U.S.A., Inc.1992-12-17
FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE (K924012)Fujifilm Medical System U.S.A., Inc.1992-10-16
XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM (K853459)Xerox Medical Systems1985-10-30

Recalls involving this device

No recalls on record reference this clearance.