510(k) K013686
- Device
- KODAK DIRECTVIEW TABLETOP CASSETTE
- Applicant
- EASTMAN KODAK COMPANY
- 510(k) number
- K013686
- Product code
- IXA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-07
- Date received
- 2001-11-07
- Regulation
- 892.1850
- Classification name
- Cassette, Radiographic Film
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUDITH A WALLACE
- Address
- 1669 Lake Ave. Rochester NY US 14652 14652
FDA Registration Numbers#
- 3002532594
- 1219183
- 3003768251
- 2431224
- 3031582434
- 2247045
- 3000126629
- 1054713
- 1317307
- 3004475699
- 3010785603
- 3014680784
- 3009077524
- 3004977335
Source Documents#
Other 510(k) Records For Product Code IXA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081557 | PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER | Jddb Manufacturing, Inc. | 2008-09-10 |
| K053173 | DS CASSETTE | Konica Minolta Medical & Graphic, Inc. | 2005-12-15 |
| K040378 | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 | Eastman Kodak Company | 2004-05-24 |
| K023020 | AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE | Agfa Corp. | 2002-09-26 |
| K021903 | KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE | Eastman Kodak Company | 2002-07-10 |
| K013229 | LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE | Ferrania USA, Inc. | 2001-10-12 |
| K012373 | LIFERAY WL CASSETTE, LIFERAY KW CASSETTE | Ferrania S.P.A. | 2001-08-09 |
| K983918 | RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) | Mastek, Inc. | 1999-03-12 |
| K980722 | TRIMAX RADIOGRAPHIC CASSETTE | Imation Corp. | 1998-03-23 |
| K963914 | CM & CM DS-7 | Konica Medical Corp. | 1997-10-08 |
| K971431 | UMI X-RAY FILM CASSETTE | Umi Intl. | 1997-05-20 |
| K970090 | SOLO-SLED | Solo-Sled, LLC | 1997-04-21 |
| K961453 | KODAK MN-R 2000 CASSETTE | Eastman Kodak Company | 1996-07-25 |
| K962336 | RADIOGRAPHIC FILM CASSETTES | Unidex Group, Inc. | 1996-07-03 |
| K953725 | CRONEX RADIATION THERAPY VERIFICATION CASSETTE | E.I. Dupont DE Nemours & Co., Inc. | 1995-09-06 |
Legacy Summary#
summary
FDA Review#
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