510(k) K993861
- Device
- FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
- Applicant
- FUJIFILM MEDICAL SYSTEM U.S.A., INC.
- 510(k) number
- K993861
- Product code
- MQB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-02-10
- Date received
- 1999-11-15
- Regulation
- 892.1680
- Classification name
- Solid State X-ray Imager (flat Panel/digital Imager)
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH M AZARY
- Address
- 419 W. Ave. Stamford CT US 06902 06902
FDA Registration Numbers#
- 3011347852
- 3003775006
- 3029916061
- 2243057
- 3023003446
- 3014634069
- 3001722928
- 3003768277
- 2024980
- 3006115340
- 3005172103
- 2424472
- 3005778458
- 3007836437
- 3004077520
- 8030112
- 1125622
- 3012855798
- 3007065358
- 3004063527
- 1317307
- 3008496839
- 3006051164
- 3011158427
- 3009963139
- 3006551157
- 3013714596
- 3011015597
- 3009134655
- 1219183
- 3017375271
- 3021059265
- 1717855
- 3007734888
- 3016256852
- 3015531968
- 3003769120
- 8020997
- 3006542593
- 3025442726
- 3008304180
- 3005810333
- 3004026651
- 3005406110
- 3013501671
- 3004706313
- 1450503
- 9613445
- 3031503890
- 9616047
- 3022131441
- 3006013411
- 3013688559
- 3005560996
- 3013186032
- 2155
- 3033527770
- 9615439
- 3005254598
- 1000181430
- 3002819275
- 3013599033
- 3017403245
- 3011416394
- 3016250464
- 3017004860
- 3015464948
- 3016674851
- 3012624817
- 2126677
- 1418964
- 3004989804
- 3009077524
- 3017585294
- 3027605321
- 3015223550
- 9614698
- 3011825597
- 3012761544
- 3012494290
Source Documents#
Other 510(k) Records For Product Code MQB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253800 | 0909FCE, 0909FCE-HS | Rayence Co., Ltd. | 2026-07-31 |
| K260820 | VIVIX-S 4386W (FXRD-4386WA) | Vieworks Co., Ltd. | 2026-06-18 |
| K252996 | Universal 1417PI | Konica Minolta Healthcare Americas, Inc. | 2026-06-12 |
| K252911 | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | 2025-10-09 |
| K250211 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2025-07-22 |
| K250665 | SKR 3000 | Konica Minolta, Inc. | 2025-06-17 |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | 2025-04-18 |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation | 2025-03-20 |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | DRTECH Corporation | 2025-03-19 |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited | 2025-03-18 |
| K244010 | ExamVue Apex | Jpi Healthcare Co, Ltd. | 2025-02-24 |
| K243171 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2024-12-19 |
| K241319 | SKR 3000 | Konica Minolta, Inc. | 2024-11-21 |
| K241125 | VIVIX-S 1751S | Vieworks Co., Ltd. | 2024-11-15 |
| K240771 | PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited | 2024-11-12 |
Legacy Summary#
summary
FDA Review#
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