510(k) K231047
- Device
- UniSyn Molecular Imaging (6-3-1)
- Applicant
- Convergent Imaging Solutions
- 510(k) number
- K231047
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-01
- Date received
- 2023-04-12
- Regulation
- 892.2050
- Classification name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Mathew Thomas
- Address
- 36 Rideau River Ln. Ottawa CA K1S 0X1 K1S 0X1
FDA Registration Numbers#
- 3006611212
- 3010687441
- 8022257
- 3011706018
- 3007137598
- 3023003446
- 3006738448
- 3006123366
- 9612330
- 3027158439
- 1000432246
- 3013283620
- 3012391689
- 3018133052
- 3008364043
- 1825014
- 3015612252
- 3014343888
- 1054415
- 9680497
- 3014232555
- 3019216
- 3013427569
- 3005517190
- 3012322232
- 3014146081
- 3015536273
- 3012761544
- 3002808157
- 3030179922
- 3005202320
- 3005916315
- 3004504920
- 3005930550
- 3011114764
- 1226773
- 3038187462
- 3007120336
- 3000237660
- 3010656400
- 3012448806
- 9615916
- 3019006180
- 3025602618
- 3009048384
- 3011657336
- 3007545404
- 3014498512
- 3013634985
- 3011205675
- 3021559833
- 2124215
- 3005919188
- 3008496839
- 3013511605
- 3033527282
- 1724955
- 3016579137
- 2031081
- 1056553
- 3016446349
- 3016832577
- 3018733944
- 1063008
- 3030228551
- 3003768251
- 9611992
- 3005914761
- 3004884150
- 3014132130
- 3022435840
- 3006579682
- 3010684280
- 3027605321
- 3022973841
- 2126677
- 3014639846
- 9614587
- 3020704423
Source Documents#
Other 510(k) Records For Product Code LLZ#
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| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | 2026-07-06 |