510(k) K974423
- Device
- ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
- Applicant
- STERLING DIAGNOSTIC IMAGING, INC.
- 510(k) number
- K974423
- Product code
- EAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-22
- Date received
- 1997-11-24
- Regulation
- 892.1960
- Classification name
- Screen, Intensifying, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEAN E BARLETT
- Address
- P.O. Box 19048 Mail Drop 102 Greenville SC US 29602 29602
FDA Registration Numbers#
- 2437780
- 2155
- 2431224
- 3010864832
- 3001722928
- 1317307
- 3042197628
- 1226003
- 3002532594
Source Documents#
Other 510(k) Records For Product Code EAM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K963913 | MD100 & MM150 | Konica Medical Corp. | 1997-10-08 |
| K954161 | JPI INTENSIFYING SCREEN | Jpi Healthcare Co, Ltd. | 1996-02-02 |
| K943823 | FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 | Fujifilm Medical System U.S.A., Inc. | 1994-08-22 |
| K943822 | FUJI UM MAMMO SERIES INTENSIFY SCREENS: | Fujifilm Medical System U.S.A., Inc. | 1994-08-22 |
| K943821 | KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC | Fujifilm Medical System U.S.A., Inc. | 1994-08-22 |
| K943425 | FUJI HG-M INTENSIFYING SCREEN | Fujifilm Medical System U.S.A., Inc. | 1994-08-17 |
| K942235 | KYOKKO GREEN SERIES INTENSIFYING SCREENS | Fujifilm Medical System U.S.A., Inc. | 1994-08-17 |
| K942805 | KYOKKO BLUE SERIES INTENSIFYING SCREENS | Fujifilm Medical System U.S.A., Inc. | 1994-07-29 |
| K942909 | KODAK INSIGHT TWIN-LOAD INSERT | Eastman Kodak Company | 1994-07-29 |
| K942399 | KYOKKO UM SERIES INTENSIFYING SCREEN | Fujifilm Medical System U.S.A., Inc. | 1994-06-10 |
| K941023 | RAREX GREEN FAST | Mci Optonix, Inc. | 1994-03-30 |
| K933161 | ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN | Dupont Medical Products | 1993-10-07 |
| K931283 | MICROVISION FAST DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1993-06-08 |
| K920200 | ULTRA-VISION DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1992-05-28 |
| K920190 | ULTRA-VISION RAPID INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1992-05-28 |
Legacy Summary#
summary
FDA Review#
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