PGY: Display, Diagnostic Radiology

510(k) review time for PGY

Across 77 510(k) clearances under PGY decided from 2018-01-01 to 2026-10-06, the median was 58 days from FDA receipt to decision. Half took between 30 and 101 days, and 80% were decided within 111 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, PGY, decisions 2018-01-01 to 2026-10-06 (n = 77)

Fastest	16
25th percentile	30
Median	58
75th percentile	101
80th percentile	111
90th percentile	139
Slowest	264

Median days by decision year, PGY (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.

Year	Median days	n
2018	28	5
2019	58	11
2020	61	12
2021	77	7
2022	60	10
2023	60	17
2024	53	10

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

PGY in the public FDA record

Records naming PGY, from openFDA (snapshot of 2026-09-15)

510(k) clearances, all years	136
Establishment listings	133

Counts of records, not of devices or events. Adverse event reports for PGY are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite PGY

1 FDA recognized consensus standard cite PGY, among them IEC 62563-2 Edition 1.0 2021-11. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

• 12-344 IEC 62563-2 Edition 1.0 2021-11 — Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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