510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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First Source Inc

Rochester, NY, US

FIRST SOURCE INC. appears in FDA device records in Rochester, NY. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for First Source Inc between 2021 and 2024. The busiest year on record is 2021, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for First Source Inc, by decision year
YearClearances
20211
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K240009iQFlex ProIZLSubstantially Equivalent
K221081iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray SystemIZLSubstantially Equivalent
K203703I-Q ViewMQBSubstantially Equivalent

Registered establishments

FDA registered establishments for First Source Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30040635273004063527FIRST SOURCE INC.3495 Winton Pl Bldg E Ste 1, Rochester, NY 14623 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2247-2024First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.Class IIOpen, Classified
Z-2246-2024First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain