Atlas FDA

VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY

FDA 510(k) clearance K021372 · decided 2002-06-07

Clearance details

K-number
K021372
Device name
VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY
Applicant
J. Morita USA, Inc.
Decision
Substantially Equivalent
Date received
2002-04-30
Decision date
2002-06-07
Days to decision
38 days
Clearance type
Traditional
Product code
EAG
Device class
2
Regulation number
872.1830
Medical specialty
Dental
Advisory committee
Dental
Location
Washington, DC, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC (K030699)J. Morita Mfg. Corp.2003-05-29
DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM (K944162)Teledyne Water Pik1994-11-29
GX-C CEPHALOMETER (K920189)Gendex Corp.1992-04-28
DIGIGRAPH DIAGNOSTIC WORK/STATION (K896099)Dolphin Imaging Systems1991-01-31
BURNETT TMJ APPLIANCE (K870243)Medrad, Inc.1987-02-24
GX CEPH (K842463)Gendex Corp.1984-08-02
CEPHALOMETER & FIXATOR (K833006)Modern Systems, Inc.1984-01-03
PLASTICEPH (K810538)Morningstar Dental Co.1981-04-29
DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH (K781287)Siemens Corp.1978-09-11

Recalls involving this device

No recalls on record reference this clearance.