510(k) K063433
- Device
- ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200
- Applicant
- MEDA LTD.
- 510(k) number
- K063433
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-01-29
- Date received
- 2006-11-13
- Regulation
- 892.1560
- Classification name
- System, Imaging, Pulsed Echo, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDWARD A KROLL
- Address
- 5905 Fawn Ln. Cleveland OH US 44141 44141
FDA Registration Numbers#
- 3013844297
- 3005099803
- 3015551113
- 3004705634
- 1450908
- 1047843
- 3005860720
- 3033527283
- 1650907
- 3012402886
- 1528028
- 3012987001
- 1930027
- 3009212453
- 3005785090
- 9615849
- 3034232408
- 3031569584
- 3011200896
- 9613067
- 3013515803
- 3003857828
- 3012038665
- 2184149
- 3015506965
- 2244725
- 2221819
- 3042225166
- 3005810333
- 3025429169
- 2133641
- 3015525240
- 3009600098
- 3010102386
- 3012104670
- 8030392
- 3010381606
- 3010457937
- 3009293490
- 3003774756
- 3033275035
- 9610632
- 3007738736
- 1226587
- 3011396687
- 2531814
- 3012981490
- 3009499478
- 2024168
- 3012428212
- 3043534483
- 2531475
- 1126271
- 3032367
- 1720929
- 3003681187
- 2522950
- 3011411309
- 3013944123
- 3010193531
- 2434141
- 3032109225
- 1061124
- 3019216
- 3006680097
- 1055236
- 1826555
- 3001763079
- 2024024
- 3005636544
- 3032109181
- 3042585081
- 3017654247
- 3014745562
- 1937397
- 8043933
- 3005875675
- 3008223664
- 3004977335
- 9710602
Source Documents#
Other 510(k) Records For Product Code IYO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253452 | Accuro 3S | Rivanna Medical, Inc. | 2026-07-24 |
| K260190 | ARTHUR | ROPCA ApS | 2026-06-18 |
| K252237 | EdgeFlow UW20 | Edgecare, Inc. | 2026-04-17 |
| K254021 | Accuro XV | Rivanna Medical, Inc. | 2026-04-09 |
| K253898 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | 2026-03-04 |
| K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | 2026-02-24 |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited | 2026-02-06 |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | 2025-09-30 |
| K250381 | Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. | 2025-08-01 |
| K243227 | B-Scan | Accutome, Inc. Doing Business AS Keeler USA | 2025-07-11 |
| K251728 | Velacur One (LI-1100) | Sonic Incytes Medical Corp | 2025-06-26 |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-06-17 |
| K243937 | Accuro 3S | Rivanna Medical, Inc. | 2025-05-23 |
| K243479 | EchoGuide (Version 1) | Sonavex, Inc. | 2025-04-23 |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Eieling Technology (Shenzhen) Limited | 2024-11-19 |
Legacy Summary#
summary
FDA Review#
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